Study of ADCT-301 in Patients With Selected Advanced Soli... | NCT03621982 | Trialant
NCT03621982
Sponsor
ADC Therapeutics S.A.
Status
Terminated
Last Update Posted
Jun 13, 2024Actual
Enrollment
78Actual
Phase
Phase 1
Conditions
Head and Neck Cancer Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Gastric Cancer
Esophageal Cancer
Pancreas Cancer
Bladder Cancer
Renal Cell Carcinoma
Melanoma
Triple-negative Breast Cancer
Ovarian Cancer
Colo-rectal Cancer
Fallopian Tube Cancer
Interventions
ADCT-301
Pembrolizumab
Countries
United States
Belgium
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03621982
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ADCT-301-103
Secondary IDs
ID
Type
Description
Link
2019-003132-23
EudraCT Number
Brief Title
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
Official Title
A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors
Acronym
Not provided
Organization
ADC Therapeutics S.A.INDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Cami in combination with pembrolizumab in solid tumors showed signals of immunomodulatory activity. However, the signals were insufficiently compelling at the tested dose/schedule to justify continuation of the study.
Expanded Access Info
No
Start Date
Nov 9, 2018Actual
Primary Completion Date
Dec 14, 2022Actual
Completion Date
Dec 14, 2022Actual
First Submitted Date
Jun 28, 2018
First Submission Date that Met QC Criteria
Aug 6, 2018
First Posted Date
Aug 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2023
Results First Submitted that Met QC Criteria
Jun 12, 2024
Results First Posted Date
Jun 13, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 12, 2024
Last Update Posted Date
Jun 13, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ADC Therapeutics S.A.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.
Detailed Description
This is a Phase 1b, multi-center, open-label study with a dose-escalation part and a dose expansion part. The duration of the study participation for each participant was defined as the time from the date of signed written informed consent to the completion of the followup period, withdrawal of consent, loss to follow-up, or death, whichever occurs first.
The study was include a Screening Period (of up to 21 days), a Treatment Period (with cycles of 3 weeks for a Q3W dosing regimen), and a Follow-up Period (approximately every 12 week visits) for up to 1 year after treatment discontinuation.
Conditions Module
Conditions
Head and Neck Cancer Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Gastric Cancer
Esophageal Cancer
Pancreas Cancer
Bladder Cancer
Renal Cell Carcinoma
Melanoma
Triple-negative Breast Cancer
Ovarian Cancer
Colo-rectal Cancer
Fallopian Tube Cancer
Keywords
Camidanlumab tesirine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
78Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ADCT-301 Monotherapy
Experimental
In Part 1 (dose escalation) participants received escalating doses of ADCT-301 as monotherapy.
Camidanlumab tesirine is administered as a 30-minute intravenous (IV) infusion on Day 1 of each cycle. Participants treated with camidanlumab tesirine as monotherapy, in the initial dose cohort will receive 20 μg/kg Q3W and the highest dose was 150 μg/kg Q3W.
Drug: ADCT-301
ADCT-301 Combination Therapy
Experimental
In Part 1 (dose escalation) participants received escalating doses of ADCT-301 in combination with pembrolizamab as combination therapy.
In Part 2 (dose expansion), participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation).
Participants treated with camidanlumab tesirine in combination with pembrolizumab, in the initial dose cohort received 30 μg/kg Q3W of camidanlumab tesirine.
Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the camidanlumab tesirine infusion).
Drug: ADCT-301
Biological: Pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ADCT-301
Drug
intravenous infusion
ADCT-301 Combination Therapy
ADCT-301 Monotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier.
Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Up to 3 years
Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.
Up to 3 years
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Up to 3 years
Number of Participants Who Experienced a SAE by CTCAE Grade
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.
Up to 3 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained prior to any procedures.
Male or female participants aged 18 years or older.
Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of Screening:
Part 1 Dose escalation camidanlumab tesirine as monotherapy:
Selected advanced solid tumors: colorectal, head and neck, NSCLC, gastric and esophageal cancers, pancreas, bladder, renal cell carcinoma, melanoma, TNBC, and ovarian/fallopian tube cancers
Part 1 Dose-escalation camidanlumab tesirine in combination with pembrolizumab:
Note: For colorectal cancer, gastric-esophageal cancer, ovarian/fallopian tube cancer, pancreatic cancers mismatch repair (MMR) / microsatellite stability (MSS) / microsatellite instability (MSI) status was mandatory. If MMR/MSS/MSI status was not available at signature of the informed consent, the test should be performed before Cycle 1 Day 1 (C1D1).
Part 2 Dose expansion camidanlumab tesirine in combination with pembrolizumab:
Group 1: One of the indications identified in Part 1, for which at least 1 response (PR or CR) was seen.
Group 2: Participants with advanced solid tumors and MSI-H/dMMR status, who had received a prior regimen containing PD-1/PD-L1 inhibitors, for which the best response was CR, PR, or SD ≥4 months, and then progressed while under treatment with the PD-1/PD-L1 inhibitor-based regimen.
Note: A maximum of 4 participants with the same indication was allowed in this basket group.
Participants who were refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
Participants with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or immune-related Response Criteria (irRC)/ immune-related Response Evaluation Criteria In Solid Tumors (irRECIST)/ immune-related Response Evaluation Criteria In Solid Tumors (iRECIST)/ immune-modified Response Evaluation Criteria in Solid Tumors (imRECIST) as per Investigator discretion.
A) For camidanlumab tesirine as monotherapy: Participant must have a site of disease amenable to biopsy and was willing to undergo fresh biopsy procedures (minimum 3 passes each) prior to first dose, according to the treating institution's guidelines.
B) Participants included in the paired-biopsy cohort must in addition be willing to undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least 1 dose of study drug.
C) For camidanlumab tesirine in combination with pembrolizumab: Participant must either had a site of disease amenable to biopsy and must provide fresh tumor biopsy prior to C1D1, or have sufficient available archival tumor tissue (biopsied after their last disease progression, and in the situation where the participant had received no additional anti-cancer therapy between their progression and C1D1). Participants were must willing to undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least 1 dose of study treatment, according to the treating institution's guidelines.
ECOG performance status 0-1.
Participant with life expectancy ≥ 3 months as per Investigator assessment.
Adequate organ function as defined by screening laboratory values within the following parameters:
Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL (off growth factors at least 72 hours).
Platelet count ≥100 × 10^3/μL without transfusion in the past 10 days.
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤5 × ULN if there is liver involvement.
Total bilirubin ≤1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN with direct bilirubin ≤1.5 × ULN).
Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft-Gault equation.
Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential (WOCBP).
Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9.5 months after the last dose of camidanlumab tesirine or 4 months after last dose of pembrolizumab, whichever is the latest. Men with female partners who were of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 6.5 months after the participant received the last dose of camidanlumab tesirine or 4 months after last dose of pembrolizumab, whichever was the latest.
Exclusion Criteria:
Participation in another investigational interventional study.
Prior therapy with a CD25 (IL-2R) antibody.
Known history of ≥Grade 3 hypersensitivity to a therapeutic antibody.
Participants with prior solid organ or allogeneic bone marrow transplant.
History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (participants with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
History of recent infection (within 4 weeks of C1D1) caused by a pathogen known to be associated with GBS, for example: herpes simplex virus 1/2 (HSV1, HSV2), varicella zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Note: An influenza test and a pathogen-directed SARS-CoV-2 test (such as polymerase chain reaction [PCR]) were mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days were allowed in the event of logistical issues for receiving the results on time).
Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Note: Testing was not mandatory to be eligible but should be considered in participants with high risk for these infections; testing was mandatory if status was unknown.
History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE version 4.0]) from acute nonhematologic toxicity (to ≤Grade 2 for neuropathy or alopecia), due to previous therapy, prior to screening.
Symptomatic CNS metastases or evidence of leptomeningeal disease (brain MRI or previously documented cerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastases were permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days were permissible if being tapered down). Participants with discrete dural metastases are eligible.
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
Active diarrhea CTCAE Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease).
Active infection requiring systemic antibiotic therapy.
Active bleeding diathesis or significant anticoagulation (international normalized ratio [INR] ≥2.0).
Breastfeeding or pregnant.
Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥160 mmHg systolic and/or ≥110 mmHg diastolic repeatedly with or without anti hypertensive medication), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, active ulceration of the upper gastrointestinal (GI) tract or GI bleeding, or severe chronic pulmonary disease.
Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor. For cytotoxic agents that have major delayed toxicity, e.g., mitomycin C and nitrosoureas, 4 weeks is indicated as washout period. For participants received systemic anticancer immunotherapies (as opposed to intralesional) that lead to activation of Teffs and/or increase the Teff/Treg ratio, such as anti-PD-1 antibodies, 4 weeks were indicated as the washout period.
Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
Participants requiring concomitant immunosuppressive agents or chronic treatment with corticosteroids except:
replacement dose steroids in the setting of adrenal insufficiency
topical, inhaled, nasal, and ophthalmic steroids are allowed.
Planned live vaccine within 30 days prior to the first dose of study treatment and during study treatment.
Congenital long QT syndrome, or a corrected QTcF interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, made the participant inappropriate for study participation or put the participant at risk.
For participants treated with camidanlumab tesirine in combination with pembrolizumab: patients intolerant to checkpoint-inhibitor or with a history of the following ≥ Grade 3 immune-related adverse events: hepatitis, renal, ocular, neurologic, cardiovascular, rheumatologic, and hematologic.
For participants treated with camidanlumab tesirine in combination with pembrolizumab: participants with a history of non-infectious pneumonitis related to prior systemic treatment and that require treatment with steroids within the last 6 months prior to enrollment.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Stanford Cancer Center
Palo Alto
California
94304
United States
Smilow Cancer Hospital Phase 1 Unit
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
In part 1, participants were to receive escalating doses of camidanlumab tesirine as monotherapy or escalating doses of camidanlumab tesirine in combination with pembrolizumab, guided by a 3+3 design. The study was terminated prior to enrollment for Part 2 of the study.
Recruitment Details
Participants were enrolled at 9 study centers in 3 countries, including the United States, Belgium, and the United Kingdom, from November 2018 to December 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 every 3 weeks (Q3W), intravenous (IV) infusion on Day 1 of each 21-day cycle.
FG001
ADCT-301 Monotherapy 30 µg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 14, 2022
Dec 8, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Camidanlumab tesirine
Pembrolizumab
Biological
intravenous infusion
ADCT-301 Combination Therapy
Keytruda
Up to 3 years
Number of Participants Who Experienced a Dose Interruption
Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Up to 3 years
Number of Participants Who Experienced a Dose Reduction
Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Up to 3 years
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
Day 1 to Day 21
Duration of Response (DOR) as Per RECIST v 1.1
DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment [EOT]/end of study [EOS]) or death due to any cause.
Up to 3 years
Progression-free Survival (PFS) as Per RECIST v 1.1
PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Up to 3 years
Overall Survival (OS)
OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Up to 3 years
Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The pharmacokinetic (PK) profile included determination of Tmax in serum Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with camidanlumab tesirine in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration is discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Cycle 1 Day 1 (C1D1), from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; Cycle 2 Day 1 (C2D1), from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
PK profile included AUC0-last of ADCT-301 in Serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included AUCinf of ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4hr, 96hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included AUCtau ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included the CL of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included the Thalf of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included determination of Cmax in serum Total antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
Number of Participants With Anti-drug Antibody (ADA) Response in Serum
ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued.
Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
C1D1, from Pre-dose to 336 hr post dose.
New Haven
Connecticut
06511
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
The Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
The START Center for Cancer Care
San Antonio
Texas
78229
United States
Institut Jules Bordet
Anderlecht
B-1070
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
University College London Hospitals NHS Foundation Trust
London
England
NW1 2PG
United Kingdom
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
FG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Participants received 20 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
FG0003 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG0048 subjects
FG0057 subjects
FG0068 subjects
FG0073 subjects
FG0081 subjects
FG0094 subjects
FG01010 subjects
FG0119 subjects
FG0124 subjects
FG0136 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0025 subjects
FG0034 subjects
FG0048 subjects
FG0055 subjects
FG0068 subjects
FG0073 subjects
FG0081 subjects
FG0094 subjects
FG01010 subjects
FG0119 subjects
FG0124 subjects
FG0136 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0102 subjects
FG0111 subjects
FG0122 subjects
FG0132 subjects
Investigator/Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0014 subjects
FG0024 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle..
BG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
BG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG012
ADCT-301 Combination Therapy 80 µg/kg +Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0015
BG0025
BG0035
BG0048
BG0057
BG0068
BG0073
BG0081
BG0094
BG01010
BG0119
BG0124
BG0136
BG01478
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier.
Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0015
OG0025
OG003
Primary
Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug and experienced TEAEs only.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Primary
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants Who Experienced a SAE by CTCAE Grade
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug. Analysis only included participants with SAEs.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Primary
Number of Participants Who Experienced a Dose Interruption
Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants Who Experienced a Dose Reduction
Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
DLT Analysis Set: The DLT-evaluable analysis set consisted of participants in Part 1 who received study drug.
Posted
Count of Participants
Participants
Day 1 to Day 21
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Secondary
Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.
Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Combination Therapy
Participants received 20, 30, 45, 60, 80 and 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Secondary
Duration of Response (DOR) as Per RECIST v 1.1
DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment [EOT]/end of study [EOS]) or death due to any cause.
Efficacy Analysis Set: This analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
Includes participants who experienced CR or PR only.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Combination Therapy
Participants received 20, 30, 45, 60, 80, 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Secondary
Progression-free Survival (PFS) as Per RECIST v 1.1
PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy
Participants received 20,30, 45, 60, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Combination Therapy
Participants received 20, 30, 45, 60,80,100,125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Secondary
Overall Survival (OS)
OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
ADCT-301 Monotherapy
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Combination Therapy
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
Secondary
Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The pharmacokinetic (PK) profile included determination of Tmax in serum Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with camidanlumab tesirine in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration is discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment. Includes participants with available data at each timepoint.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
days
Cycle 1 Day 1 (C1D1), from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; Cycle 2 Day 1 (C2D1), from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Secondary
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
PK profile included AUC0-last of ADCT-301 in Serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included AUCinf of ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*µg/L
C1D1, from Pre-dose to 4hr, 96hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included AUCtau ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*µg/L
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included the CL of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/day
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Apparent Terminal Elimination Half-life (Thalf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199
The PK profile included the Thalf of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
days
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Maximum Concentration (Cmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
The PK profile included determination of Cmax in serum Total antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.
Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment.
The overall number of participants analyzed represents the number of participants with available PK data at any timepoint.
Includes participants with available data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/L
C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
ID
Title
Description
OG000
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG001
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Secondary
Number of Participants With Anti-drug Antibody (ADA) Response in Serum
ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued.
Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Pharmacodynamic Analysis Set: The pharmacodynamic analysis set consisted of all participants who received study drug and had at least 1 valid pharmacodynamics/biomarker assessment. The data was pooled overall as pre-specified in protocol.
Includes participants with available data at each timepoint.
Posted
Count of Participants
Participants
C1D1, from Pre-dose to 336 hr post dose.
ID
Title
Description
OG000
Overall Study
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion)
Units
Time Frame
All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ADCT-301 Monotherapy 20 µg/kg
Part 1 (dose escalation): 20 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
2
3
2
3
3
3
EG001
ADCT-301 Monotherapy 30 µg/kg
Part 1 (dose escalation): 30 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
4
5
1
5
5
5
EG002
ADCT-301 Monotherapy 45 µg/kg
Part 1 (dose escalation): 45 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
4
5
2
5
5
5
EG003
ADCT-301 Monotherapy 60 µg/kg
Part 1 (dose escalation): 60 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
3
5
3
5
5
5
EG004
ADCT-301 Monotherapy 80 µg/kg
Part 1 (dose escalation): 80 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
8
8
3
8
8
8
EG005
ADCT-301 Monotherapy 100 µg/kg
Part 1 (dose escalation): 100 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
4
7
1
7
7
7
EG006
ADCT-301 Monotherapy 125 µg/kg
Part 1 (dose escalation): 125 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
6
8
3
8
8
8
EG007
ADCT-301 Monotherapy 150 µg/kg
Part 1 (dose escalation): 150 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
3
3
3
3
3
3
EG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 20 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
0
1
1
1
1
1
EG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 30 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
3
4
3
4
4
4
EG010
ADCT Combination Therapy 45 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 45 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
8
10
5
10
10
10
EG011
ADCT Combination Therapy 60 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 60 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
4
9
8
9
9
9
EG012
ADCT Combination Therapy 80 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 80 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
2
4
2
4
4
4
EG013
ADCT Combination Therapy 100 µg/kg + Pemb
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 100 µg/kg.
Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
2
6
5
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Disease progression
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Immune-mediated adverse reaction
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0024 events2 affected5 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected7 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0105 events4 affected10 at risk
EG0114 events3 affected9 at risk
EG0120 events0 affected4 at risk
EG0133 events3 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blepharitis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eye discharge
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected5 at risk
EG0024 events4 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0023 events3 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Noninfective sialoadenitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Salivary duct inflammation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected5 at risk
EG0023 events3 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Breakthrough pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Facial pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Localised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Suprapubic pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Catheter site dermatitis
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gamma-glutamyltransferase
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Troponin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D007674
Kidney Diseases
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D001943
Breast Neoplasms
D001941
Breast Diseases
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D005833
Genital Neoplasms, Female
D000091662
Genital Diseases
D006058
Gonadal Disorders
D015179
Colorectal Neoplasms
D007414
Intestinal Neoplasms
D003108
Colonic Diseases
D007410
Intestinal Diseases
D005184
Fallopian Tube Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C582435
pembrolizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0114 subjects
FG0120 subjects
FG0132 subjects
8 subjects
FG0054 subjects
FG0066 subjects
FG0073 subjects
FG0080 subjects
FG0093 subjects
FG0108 subjects
FG0114 subjects
FG0122 subjects
FG0132 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Between 18 and 65 years
BG0002
BG0012
BG0024
BG0033
BG0044
BG0052
BG0066
BG0073
BG0080
BG0093
BG0105
BG0112
BG0122
BG0134
BG01442
>=65 years
BG0001
BG0013
BG0021
BG0032
BG0044
BG0055
BG0062
BG0070
BG0081
BG0091
BG0105
BG0117
BG0122
BG0132
BG01436
2
BG0033
BG0043
BG0053
BG0062
BG0071
BG0080
BG0093
BG0107
BG0117
BG0123
BG0133
BG01441
Male
BG0001
BG0013
BG0023
BG0032
BG0045
BG0054
BG0066
BG0072
BG0081
BG0091
BG0103
BG0112
BG0121
BG0133
BG01437
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0142
Not Hispanic or Latino
BG0002
BG0014
BG0025
BG0035
BG0048
BG0057
BG0068
BG0073
BG0080
BG0094
BG01010
BG0119
BG0124
BG0135
BG01474
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0131
BG0142
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Asian
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0103
BG0110
BG0120
BG0130
BG0144
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0141
Black or African American
BG0000
BG0011
BG0021
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0143
White
BG0003
BG0014
BG0024
BG0034
BG0047
BG0057
BG0068
BG0073
BG0080
BG0094
BG0107
BG0119
BG0123
BG0135
BG01468
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0131
BG0142
5
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
5
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0052
OG0061
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0130
Grade 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
Grade 3
Title
Measurements
OG0003
OG0014
OG0023
OG003
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0021
OG003
Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
OG0033
OG0043
OG0051
OG0063
OG0073
OG0081
OG0093
OG0105
OG0118
OG0122
OG0135
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0002
OG0011
OG0022
OG0033
OG0043
OG0051
OG0063
OG0073
OG0081
OG0093
OG0105
OG0118
OG0122
OG0135
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3
Title
Measurements
OG0002
OG0011
OG0021
OG003
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0021
OG003
Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combined Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combined Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combined Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combined Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combined Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combined Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0068
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0111
OG0120
OG0131
Units
Counts
Participants
OG00044
OG00133
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG00115.2(5.1 to 31.9)
Units
Counts
Participants
OG0000
OG0015
Title
Denominators
Categories
Title
Measurements
OG0019.26(3.15 to NA)Upper limit could not be calculated as not enough participants achieved a response.
Participants
OG00044
OG00133
Title
Denominators
Categories
Title
Measurements
OG0001.35(1.18 to 1.38)
OG0011.41(1.25 to 2.10)
OG00044
OG00133
Title
Denominators
Categories
Title
Measurements
OG0004.37(2.99 to 6.74)
OG0017.59(4.11 to 10.61)
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0067
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG0000.0750± 81.1
OG0010.0770± 82.4
OG0020.0780± 76.2
OG003
Total Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Conjugated Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Total Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0067
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG000229± 520
OG001464± 65.8
OG002484± 224
OG003
Total Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Conjugated Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Total Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0034
OG0047
OG0057
OG0066
OG0073
OG0081
OG0091
OG0104
OG0118
OG0122
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG0047
ParticipantsOG0057
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0122
ParticipantsOG0136
Title
Measurements
OG000823± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG001907± 26.6
OG0021000± 14.7
OG003
Total Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Conjugated Antibody Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Total Antibody Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0001
OG0014
OG0022
OG0034
OG0044
OG0055
OG0064
OG0073
OG0081
OG0092
OG0105
OG0116
OG0122
OG0133
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
Total Antibody Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Conjugated Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
Total Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0034
OG0044
OG0055
OG0064
OG0073
OG0081
OG0092
OG0105
OG0116
OG0122
OG0133
Title
Denominators
Categories
Conjugated Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001.00± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.00± 0.175
OG0021.00± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG003
Total Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0001
OG0014
OG0022
OG0034
OG0047
OG0057
OG0066
OG0073
OG0081
OG0092
OG0105
OG0118
OG0122
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG0047
ParticipantsOG0057
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0122
ParticipantsOG0136
Title
Measurements
OG0000.940± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.85± 74.0
OG0022.92± 15.9
OG003
Total Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Conjugated Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
Total Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0034
OG0047
OG0057
OG0066
OG0073
OG0081
OG0092
OG0105
OG0118
OG0122
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG0047
ParticipantsOG0057
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG0122
ParticipantsOG0136
Title
Measurements
OG0001.39± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.93± 40.1
OG0021.49± 5.47
OG003
Total Antibody Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Conjugated Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Total Antibody Cycle 2
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG003
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG004
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG005
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG006
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG007
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
OG008
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG009
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG010
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG011
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG012
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
OG013
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
Units
Counts
Participants
OG0003
OG0015
OG0025
OG0035
OG0048
OG0057
OG0067
OG0073
OG0081
OG0094
OG01010
OG0119
OG0124
OG0136
Title
Denominators
Categories
Conjugated Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG000317± 33.2
OG001314± 34.2
OG002433± 35.0
OG003
Total Antibody Cycle 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
Unconjugated SG3199 Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Conjugated Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Total Antibody Cycle 2
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Unconjugated SG3199 Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Counts
Participants
OG00078
Title
Denominators
Categories
Positive ADA predose
Title
Measurements
OG0001
Positive ADA post dose
Title
Measurements
OG0000
Positive ADA at any time
Title
Measurements
OG0001
Positive ADA before and after dose
Title
Measurements
OG0001
1 events
1 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0131 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0132 events1 affected6 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0092 events1 affected4 at risk
EG0100 events0 affected10 at risk
EG0112 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0131 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
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EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0103 events2 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0042 events1 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0121 events1 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
2 events
2 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0042 events2 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0131 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected10 at risk
EG0112 events2 affected9 at risk
EG0120 events0 affected4 at risk
EG0132 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0093 events3 affected4 at risk
EG0100 events0 affected10 at risk
EG0112 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0131 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected4 at risk
EG0131 events1 affected6 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected4 at risk
EG0130 events0 affected6 at risk
1
OG0041
OG0051
OG0062
OG0071
OG0080
OG0091
OG0102
OG0110
OG0122
OG0131
2
OG0045
OG0052
OG0064
OG0071
OG0081
OG0092
OG0107
OG0116
OG0122
OG0135
1
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0112
OG0120
OG0130
0
OG0041
OG0051
OG0061
OG0071
OG0080
OG0091
OG0100
OG0111
OG0120
OG0130
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0121
OG0131
2
OG0042
OG0050
OG0062
OG0071
OG0081
OG0092
OG0105
OG0117
OG0121
OG0134
1
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
0
OG0041
OG0051
OG0061
OG0071
OG0080
OG0091
OG0100
OG0111
OG0120
OG0130
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
0.0940
± 54.8
OG0040.0560± 50.3
OG0050.0760± 37.0
OG0060.0840± 48.6
OG0070.0770± 87.8
OG0080.0350± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0090.0290± 15.9
OG0100.0720± 1522
OG0110.108± 114
OG0120.0620± 163
OG0130.121± 90.2
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG0000.0750± 81.1
OG0010.0980± 87.2
OG0020.0780± 76.2
OG0030.0730± 54.2
OG0040.0790± 70.2
OG0050.0910± 56.3
OG0060.0700± 43.1
OG0070.121± 65.9
OG0080.0350± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0090.0430± 112
OG0100.0830± 112
OG0110.112± 99.6
OG0120.0620± 163
OG0130.121± 90.2
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0040.146± 37.8
OG0050.116± 54.4
OG0060.192± 18.6
OG0070.160± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0102.84± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.178± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0120.161± 1.52
OG0130.0890± 152
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG0000.0670± 193
OG0010.0280± 33.1
OG0020.0720± 130
OG0030.115± 94.2
OG0040.0280± 15.7
OG0050.0540± 78.3
OG0060.0310± 1.12
OG0070.0470± 160
OG0080.0330± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0090.0740± 92.5
OG0100.110± 542
OG0110.0590± 131
OG0120.0510± 147
OG0130.171± 9.93
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG0000.0670± 193
OG0010.0280± 33.1
OG0020.0440± 122
OG0030.0760± 115
OG0040.112± 91.9
OG0050.0550± 79.5
OG0060.0310± 1.12
OG0070.0860± 173
OG0080.0330± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0090.0740± 92.5
OG0100.0690± 112
OG0110.102± 106
OG0120.101± 130
OG0130.171± 9.93
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG0131
Title
Measurements
OG0030.168± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0040.174± 0
OG0050.280± 4298
OG0060.170± 3.17
OG0101.12± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.169± 2.32
OG0120.0320± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0130.161± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
2067
± 93.6
OG0041954± 31.9
OG0053440± 66.6
OG0065848± 53.5
OG0075571± 61.9
OG008564± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009655± 53.6
OG0101124± 47.0
OG0111737± 35.6
OG012814± 428
OG0133863± 33.3
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG000294± 598
OG001636± 113
OG002647± 222
OG0032857± 67.7
OG0043025± 37.0
OG0054938± 67.4
OG0068812± 74.6
OG0079078± 48.4
OG008955± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009965± 73.7
OG0101508± 52.7
OG0112470± 42.1
OG0121172± 557
OG0137274± 24.0
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0040.00100± 322
OG0050.00600± 751
OG0060.00300± 298
OG0070.00100± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0100.0110± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.00100± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0120.00100± 57.2
OG0130.00200± 228
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG000588± 17.3
OG001676± 92.4
OG002898± 95.5
OG0032386± 126
OG0042668± 44.0
OG0054025± 101
OG0068305± 22.0
OG0076599± 46.1
OG0082421± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009825± 37.6
OG0101392± 57.0
OG0111716± 84.6
OG0121386± 145
OG0134535± 66.2
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG000769± 14.6
OG001880± 107
OG0021060± 105
OG0033740± 116
OG0044910± 35.8
OG0055815± 72.2
OG00611879± 18.8
OG0079027± 48.0
OG0084796± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091128± 47.5
OG0101653± 57.3
OG0112609± 74.9
OG0123203± 41.3
OG0137077± 44.1
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG0131
Title
Measurements
OG0030.00100± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0040.00400± 1630
OG0050.00200± 14068
OG0060.0320± 3.13
OG0100.00600± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.00300± 293
OG0120.00300± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0130.00100± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
2552
± 98.1
OG0042259± 30.1
OG0053708± 66.0
OG0067420± 30.9
OG0078031± 22.6
OG008678± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009873± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0102058± 19.7
OG0112059± 30.1
OG0122725± 51.5
OG0134556± 34.4
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0104
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001068± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0021331± 2.40
OG0035768± 10.7
OG0043962± 21.8
OG0056594± 36.2
OG00613018± 40.3
OG0079578± 50.1
OG0092107± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0102083± 18.4
OG0113552± 23.6
OG0124157± 77.3
OG0137077± 8.27
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001776± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011110± 70.5
OG0021516± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0033719± 132
OG0042956± 47.2
OG0056084± 26.4
OG0069238± 27.5
OG0077885± 31.4
OG0082882± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091171± 5.95
OG0101816± 46.1
OG0112467± 44.6
OG0122975± 18.4
OG0135440± 64.1
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0002562± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011302± 88.4
OG0022217± 34.2
OG0034490± 110
OG0045565± 35.4
OG0056486± 80.0
OG00613483± 22.9
OG00712197± 40.7
OG0085399± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091856± 4.69
OG0102861± 43.3
OG0113720± 47.5
OG0124887± 27.6
OG0138920± 45.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
1.09
± 7.42
OG0041.01± 0.621
OG0051.02± 2.41
OG0061.04± 4.67
OG0071.03± 2.39
OG0081.00± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091.00± 0.123
OG0101.01± 1.05
OG0111.00± 0.570
OG0121.00± 0.258
OG0131.02± 1.28
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001.00± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.00± 0.248
OG0021.00± 0.124
OG0031.03± 3.59
OG0041.01± 0.819
OG0051.02± 3.12
OG0061.05± 6.87
OG0071.05± 4.03
OG0081.10± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091.00± 0.257
OG0101.03± 3.73
OG0111.00± 0.305
OG0121.01± 0.757
OG0131.04± 3.01
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
1.37
± 60.5
OG0042.04± 18.3
OG0051.84± 52.7
OG0061.22± 16.4
OG0071.36± 12.8
OG0082.53± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0092.30± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0101.35± 22.6
OG0111.33± 34.4
OG0121.46± 40.3
OG0131.36± 31.5
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0104
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0000.869± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0022.60± 3.98
OG0030.928± 0.345
OG0041.35± 27.8
OG0051.24± 32.8
OG0060.880± 27.4
OG0071.16± 18.9
OG0091.15± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0101.27± 21.0
OG0111.12± 24.4
OG0121.14± 63.2
OG0130.809± 13.1
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0000.544± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0012.02± 69.3
OG0021.91± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0031.01± 105
OG0041.57± 18.3
OG0051.18± 21.2
OG0061.02± 19.9
OG0071.16± 17.3
OG0081.82± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0092.11± 6.07
OG0101.44± 35.4
OG0111.43± 43.1
OG0121.47± 10.9
OG0131.23± 30.7
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0000.449± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0012.05± 86.9
OG0021.43± 48.0
OG0031.02± 88.1
OG0040.994± 20.9
OG0051.25± 64.9
OG0060.830± 15.4
OG0071.04± 26.5
OG0081.16± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091.58± 16.8
OG0101.08± 28.9
OG0111.13± 36.7
OG0121.07± 19.8
OG0130.890± 15.3
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
2.41
± 75.5
OG0041.96± 9.91
OG0052.30± 54.5
OG0063.66± 44.5
OG0073.97± 17.9
OG0081.55± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091.42± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0102.64± 12.8
OG0111.93± 20.8
OG0122.61± 9.30
OG0132.89± 41.8
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0104
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001.41± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0021.36± 11.2
OG0033.22± 22.8
OG0041.95± 13.7
OG0052.49± 43.2
OG0063.78± 42.4
OG0072.79± 70.8
OG0092.33± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0102.16± 16.8
OG0112.10± 20.0
OG0122.55± 13.0
OG0133.00± 18.9
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0001.75± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.89± 25.6
OG0021.88± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0033.95± 118
OG0042.49± 29.0
OG0053.15± 43.5
OG0064.08± 33.4
OG0073.28± 51.7
OG0082.60± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0091.85± 31.9
OG0102.54± 42.4
OG0112.24± 29.7
OG0122.30± 21.4
OG0133.32± 20.0
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG0115
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0002.22± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0011.99± 27.1
OG0022.10± 17.4
OG0032.86± 66.3
OG0042.67± 29.1
OG0052.58± 79.1
OG0063.92± 48.2
OG0074.70± 27.6
OG0086.09± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0092.37± 18.7
OG0103.13± 47.0
OG0112.24± 22.5
OG0122.97± 20.1
OG0133.98± 35.1
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
889
± 34.3
OG004901± 33.6
OG0051328± 38.0
OG0062017± 20.4
OG0071990± 1.73
OG008408± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009389± 31.3
OG010594± 46.2
OG011750± 17.1
OG012954± 75.0
OG0131937± 150
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0119
ParticipantsOG0124
ParticipantsOG0136
Title
Measurements
OG000411± 39.2
OG001377± 35.7
OG002552± 31.5
OG0031077± 23.7
OG0041270± 28.6
OG0051740± 32.5
OG0062442± 25.6
OG0072228± 18.2
OG008488± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009507± 25.8
OG010719± 39.2
OG011946± 18.8
OG0121209± 76.2
OG0132836± 126
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0133
Title
Measurements
OG0040.0120± 28.3
OG0050.0170± 35.8
OG0060.0140± 21.8
OG0070.0140± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0100.0110± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.0120± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0120.0130± 5.97
OG0130.0250± 185
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG000405± 12.8
OG001448± 109
OG002497± 28.6
OG003999± 78.3
OG004939± 34.5
OG0051527± 43.7
OG0062150± 11.1
OG0072208± 13.2
OG0081270± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009407± 43.0
OG010603± 38.5
OG011862± 82.7
OG0121089± 125
OG0131297± 46.4
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0107
ParticipantsOG0117
ParticipantsOG0123
ParticipantsOG0133
Title
Measurements
OG000490± 2.60
OG001560± 122
OG002592± 24.7
OG0031420± 62.3
OG0041354± 22.9
OG0051797± 35.1
OG0062624± 2.67
OG0072907± 7.98
OG0081660± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG009463± 44.6
OG010745± 29.7
OG0111149± 71.1
OG0121355± 128
OG0131690± 24.9
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG0131
Title
Measurements
OG0030.0130± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0040.0130± 3.82
OG0050.0110± 3.23
OG0060.0170± 8.29
OG0100.0100± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0110.0100± 26.4
OG0120.0190± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.
OG0130.0120± NAData not available due to insufficient number of observations to determine geometric coefficient of variation.