Study of Intratumorally Administered Stimulator of Interf... | NCT04144140 | Trialant
NCT04144140
Sponsor
Eisai Inc.
Status
Terminated
Last Update Posted
Mar 7, 2024Actual
Enrollment
24Actual
Phase
Phase 1
Conditions
Lymphoma
Advanced Solid Tumors
Interventions
E7766
Countries
United States
France
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04144140
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E7766-G000-101
Secondary IDs
ID
Type
Description
Link
2019-000160-17
EudraCT Number
Brief Title
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
Official Title
An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated earlier due to a business decision; which was unrelated to safety. In addition, there was no clinical activity data that informed the decision.
Expanded Access Info
No
Start Date
Feb 24, 2020Actual
Primary Completion Date
Jul 26, 2022Actual
Completion Date
Jul 26, 2022Actual
First Submitted Date
Oct 28, 2019
First Submission Date that Met QC Criteria
Oct 28, 2019
First Posted Date
Oct 30, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jul 25, 2023
Results First Submitted that Met QC Criteria
Jul 25, 2023
Results First Posted Date
Mar 7, 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
Jul 25, 2023
Last Update Posted Date
Mar 7, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Inc.INDUSTRY
Collaborators
Name
Class
H3 Biomedicine Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
Detailed Description
The Phase 1/1b study consist of two parts: Dose Escalation and Dose Expansion. In the Dose Escalation Part, E7766 will be administered intratumorally in participants with advanced solid tumors or lymphomas to assess safety/tolerability profile of E7766 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7766. In the Dose Expansion Part, E7766 at RP2D will be administered to participants with melanoma, head and neck squamous cell carcinoma (HNSCC), breast cancer, colorectal cancer, and/or other tumors including lymphomas to confirm safety and assess preliminary clinical activity of E7766 as a single agent. Clinical activity will be evaluated by objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) on treatment with E7766.
Conditions Module
Conditions
Lymphoma
Advanced Solid Tumors
Keywords
Advanced Solid Tumors
E7766
Intratumoral Injection
Stimulator of Interferon Genes Agonist
Interferons
Antineoplastic Agents
Lymphoma
Melanoma
Breast Cancer
Colorectal Cancer
Squamous Cell Carcinoma of the Head and Neck
Oesophageal Squamous Cell Carcinoma
Adenocarcinoma of the Gastroesophageal Junction or Gastric
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
24Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation: Advanced Solid Tumors or Lymphomas
Experimental
Drug: E7766
Dose Expansion: Advanced Solid Tumors or Lymphomas
Experimental
Dose identified from dose escalation part for E7766 will be used in dose expansion part.
Drug: E7766
Interventions
Name
Type
Description
Arm Group Labels
Other Names
E7766
Drug
E7766, solution, intratumorally
Dose Escalation: Advanced Solid Tumors or Lymphomas
Dose Expansion: Advanced Solid Tumors or Lymphomas
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were predefined as any of the following toxicities occurring during Cycle 1 and were assessed by the investigator according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version (v) 5.0. as related to E7766. Nonhematologic toxicity greater than or equal to (>=) Grade 3 (NCI CTCAE v. 5.0), except Grade 3 fatigue less than (<) 5 days. Asymptomatic Grade 3 or 4 laboratory abnormalities that were corrected within 72 hours. >=Grade 3 nausea, vomiting, and diarrhea unless lasting greater than (>) 48 hours despite optimal supportive care. Hematologic toxicity: Grade 4 neutropenia for >=5 days, or febrile neutropenia. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with hemorrhage. A DLT may have continued treatment at a reduced dose if the DLT had resolved and in the opinion of the investigator the participant was benefiting from treatment. In case of recurrence of the DLT at a lower dose, E7766 treatment was discontinued.
Cycle 1 (Cycle length= 21 days)
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 90 days after the participant's last dose) or start day of another anticancer therapy, whichever is earlier; or in case participant has initiated new anticancer therapy within 30 days, then AEs occurring for 30 days following the last dose of E7766, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)
Dose Expansion Part: Objective Response Rate Based on Modified Response Evaluation Criteria In Solid Tumors (mRECIST) v1.1
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
Secondary Outcomes
Measure
Description
Time Frame
Dose Escalation Part: ORR Based on iRECIST
ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.
Participants must have a minimum of one injectable lesion which is also accessible for biopsy, and if available, one other measurable lesion also accessible for biopsy.
An injectable lesion is defined as being measurable (defined below) with a maximum of 3.0 centimeter (cm) longest diameter, accessible for injection as judged by the investigator, and has not been subjected to any prior intratumoral treatment or radiotherapy. Lesions selected for injection must not be too close to a major vessel and not be associated with increased risk of bleeding, example, subcapsular liver lesions or hypervascular tumors.
Measurable lesions are:
Solid tumors: At least 1 lesion of greater than or equal to (>=1) cm by longest axial diameter or >=1.5 cm short axis diameter if a nodal lesion, which is serially measurable according to modified Response evaluation criteria in solid tumors (RECIST) 1.1 using CT/MRI or photography. Lesions that have had external beam radiotherapy or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progression to be deemed a target lesion.
Lymphoma: At least 1 lymph node with a longest diameter greater than (>)1.5 cm or an extranodal lesion with a longest diameter >1.0 cm
Participants with prior Hepatitis B or C are eligible if they have adequate liver function
Adequate bone marrow function:
Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (>=1.0*10^3 per microliter [/mcL])
Platelets >=75,000/mm^3 (>=75*10^ 9 per liter [/L])
Hemoglobin >=9.0 grams per deciliter (g/dL)
Adequate liver function defined by:
Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=)1.5
Total bilirubin <=1.5*upper limit of the normal range (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*ULN (in the case of liver metastasis <=5*ULN) unless there are bone metastases. Participants with ALP values >3*ULN and known to have bone metastases can be included.
Exclusion Criteria:
Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.
Known human immunodeficiency virus (HIV) infection.
Major surgery within 4 weeks before the first dose of study drug.
Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or progressing brain metastases (except in the posterior fossa or involving the meninges) previously treated with brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT) and/or surgery are allowed as long as the participant is asymptomatic neurologically and does not require immediate local intervention (radiotherapy and/or surgery). In addition, participants must be off immunosuppressive doses of systemic steroids (>10 milligram per day (mg/d) prednisone or equivalent) for at least 4 weeks before study drug administration.
Prolongation of corrected QT (QTc) interval to >450 millisecond (msec) for males and females when electrolytes balance is normal.
Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 units per liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (total abstinence [if it is their preferred and usual lifestyle], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 180 days after study drug discontinuation. For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide. If currently abstinent, the participant must agree to use a highly effective method as described above if she becomes sexually active during the study period or for 180 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 180 days after study drug discontinuation.
Male participants who are partners of women of childbearing potential must use a condom and spermicide and their female partners if of childbearing potential must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drug(s), throughout the entire study period, and for 180 days after the last dose of study drug, unless the male participants are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile. No sperm donation is allowed during the study period or for 180 days after study drug discontinuation.
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
Yale New Haven Hospital
New Haven
Connecticut
06510
United States
University of Miami Hospital Sylvester Comprehensive Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 31 participants were screened, of which 7 were screen failures and 24 were enrolled to receive study treatment in the Dose Escalation Part of this study. The study was terminated due to sponsor's strategic decision, which is unrelated to safety, therefore no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Recruitment Details
Participants took part in the study at 8 investigative sites in the United States, France, and United Kingdom from 24 February 2020 to 26 July 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 microgram (mcg), injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until progressive disease (PD) or until other discontinuation criteria whichever occurred first.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
Dec 4, 2019
Jul 25, 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
No data available
No data is available for this block.
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
From date of first dose of study drug until confirmed CR or PR (up to 29 months)
Dose Expansion Part: ORR Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
From date of first dose of study drug until confirmed iCR or iPR (up to 29 months)
Dose Expansion Part: Duration of Response (DOR) Based on mRECIST v1.1
DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1 as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
From first documented confirmed CR or PR until first documentation of PD or death (up to 29 months)
Dose Expansion Part: DOR Based on iRECIST
DOR: time from date of first observation of response (iPR or iCR) to date of the first observation of progression based on iRECIST 1.1 as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 29 months)
Dose Expansion Part: Disease Control Rate (DCR) Based on mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD) based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been >=5 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 29 months)
Dose Expansion Part: DCR Based on iRECIST
DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD >=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 29 months)
From date of first dose of study drug until confirmed iCR or iPR (up to 6 months and 18 days)
Dose Escalation Part: ORR Based on mRECIST v1.1
ORR was defined as the percentage of participants with a BOR of CR or PR for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
From date of first dose of study drug until confirmed CR or PR (up to 6 months and 18 days)
Dose Escalation Part: DOR Based on iRECIST
DOR: time from date of first observation of response (iPR or iCR) to date of the first observation of progression based on iRECIST 1.1 as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 6 months and 18 days)
Dose Escalation Part: DOR Based on mRECIST v1.1
DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
From first documented confirmed CR or PR until first documentation of PD or death (up to 6 months and 18 days)
Dose Escalation Part: DCR Based on iRECIST
DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD >=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 6 months and 18 days)
Dose Escalation Part: DCR Based on mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of CR or PR, or SD based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been >=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 6 months and 18 days)
Cmax: Maximum Observed Plasma Concentration for E7766
Cmax was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7766
Tmax was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
Part: AUC(0-t): Area Under the Plasma Concentration From Time Zero to Last Curve for E7766
AUC was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
AUC(0-inf): Area Under the Plasma Concentration From Time Zero to Infinity Curve for E7766
AUC(0-inf) was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
t1/2: Terminal Elimination Half-life for E7766
t1/2 was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7766
CL/F was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: Vd/F: Apparent Volume of Distribution for E7766
Vd/F was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: CLr: Renal Clearance for E7766
CLr was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: Rac (Cmax): Accumulation Ratio Based on Cmax for E7766
Rac (Cmax) was calculated as the ratio of Cmax on Cycle 1 Day 15 divided by Cmax on Cycle 1 Day 1. Accumulation ratio was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: Rac (AUC0-t): Accumulation Ratio Based on AUC for E7766
Rac (AUC0-t) was calculated as the ratio of AUC(0-t) on Cycle 1 Day 15 divided by AUC(0-t) on Cycle 1 Day 1. Accumulation ratio was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: Percentage (Fraction) Excreted (fe) in Urine for E7766
fe was defined as fraction of administered drug (E7766) excreted/recovered in urine. fe was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Dose Escalation Part: Percentage (Fraction) Excreted (fe) in Feces for E7766
fe was defined as fraction of administered drug (E7766) excreted/recovered in feces. fe was quantified using validated liquid LC-MS/MS methods.
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
Progression Free Survival (PFS) Based on mRECIST v1.1
PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on mRECIST v1.1 as per investigator assessment. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
PFS Based on iRECIST
PFS was defined as the time from the first dose date to the date of iPD or date of death (whichever occurred first) according to iRECIST version 1.1 as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
Overall Survival (OS)
OS was measured from the date of first dose of study drug until date of death from any cause. OS event was defined as deaths no later than data cut off date or date of death of a participant.
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
Percent Change From Baseline in Tumor Size
Percent change from baseline in tumor size was calculated for the first injected lesion based on Investigator Assessment.
Baseline to up to 6 months and 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
Miami
Florida
33136
United States
Massachusetts General Hospital Cancer Center
Boston
Massachusetts
02114
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Pittsburgh Medical Center and Hillman Cancer Center
Pittsburgh
Pennsylvania
15232
United States
Institut Gustave Roussy
Villejuif
94805
France
Samsung Medical Center
Seoul
06351
South Korea
Hospital Universitario Vall d'Hebrón
Barcelona
08035
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
START Madrid
Madrid
28050
Spain
INCLIVA Hospital Clínico Universitario de Valencia
Valencia
46010
Spain
Imperial College Healthcare NHS Trust
London
W12 0HS
United Kingdom
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
FG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
FG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
FG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
FG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
FG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part of E7766. Hence, no data collection and analysis were done during Dose Expansion part of this study.
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG00311 subjects
FG0046 subjects
FG0051 subjects
FG0060 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG00311 subjects
FG0046 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG00311
BG0046
BG0051
BG00624
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.0± 4.24
BG00153.5± 13.44
BG00249.5± 12.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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
Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were predefined as any of the following toxicities occurring during Cycle 1 and were assessed by the investigator according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version (v) 5.0. as related to E7766. Nonhematologic toxicity greater than or equal to (>=) Grade 3 (NCI CTCAE v. 5.0), except Grade 3 fatigue less than (<) 5 days. Asymptomatic Grade 3 or 4 laboratory abnormalities that were corrected within 72 hours. >=Grade 3 nausea, vomiting, and diarrhea unless lasting greater than (>) 48 hours despite optimal supportive care. Hematologic toxicity: Grade 4 neutropenia for >=5 days, or febrile neutropenia. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with hemorrhage. A DLT may have continued treatment at a reduced dose if the DLT had resolved and in the opinion of the investigator the participant was benefiting from treatment. In case of recurrence of the DLT at a lower dose, E7766 treatment was discontinued.
The DLT analysis set included all participants in the Dose Escalation part who completed Cycle 1 without incurring certain major protocol deviations (for instance those related to dosing or others identified before database lock) with at least 2 E7766 injections during Cycle 1 and were evaluable for DLT, or participants who experienced DLT during Cycle 1.
Posted
Count of Participants
Participants
Cycle 1 (Cycle length= 21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 90 days after the participant's last dose) or start day of another anticancer therapy, whichever is earlier; or in case participant has initiated new anticancer therapy within 30 days, then AEs occurring for 30 days following the last dose of E7766, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
The safety analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
Count of Participants
Participants
From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Primary
Dose Expansion Part: Objective Response Rate Based on Modified Response Evaluation Criteria In Solid Tumors (mRECIST) v1.1
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From date of first dose of study drug until confirmed CR or PR (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Primary
Dose Expansion Part: ORR Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From date of first dose of study drug until confirmed iCR or iPR (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
Primary
Dose Expansion Part: Duration of Response (DOR) Based on mRECIST v1.1
DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1 as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From first documented confirmed CR or PR until first documentation of PD or death (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Primary
Dose Expansion Part: DOR Based on iRECIST
DOR: time from date of first observation of response (iPR or iCR) to date of the first observation of progression based on iRECIST 1.1 as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
Primary
Dose Expansion Part: Disease Control Rate (DCR) Based on mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD) based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been >=5 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Primary
Dose Expansion Part: DCR Based on iRECIST
DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD >=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 29 months)
ID
Title
Description
OG000
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part of E7766. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
Secondary
Dose Escalation Part: ORR Based on iRECIST
ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
The full analysis set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From date of first dose of study drug until confirmed iCR or iPR (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: ORR Based on mRECIST v1.1
ORR was defined as the percentage of participants with a BOR of CR or PR for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
The full analysis set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From date of first dose of study drug until confirmed CR or PR (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: DOR Based on iRECIST
DOR: time from date of first observation of response (iPR or iCR) to date of the first observation of progression based on iRECIST 1.1 as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The full analysis set included all participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed signifies participants who had overall response (OR) (CR or PR) as per Investigator Assessment.
Posted
From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: DOR Based on mRECIST v1.1
DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.
The full analysis set included all participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment.
Posted
From first documented confirmed CR or PR until first documentation of PD or death (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Secondary
Dose Escalation Part: DCR Based on iRECIST
DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD >=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.
The full analysis set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: DCR Based on mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of CR or PR, or SD based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been >=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
The full analysis set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 6 months and 18 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Cmax: Maximum Observed Plasma Concentration for E7766
Cmax was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
The Pharmacokinetic (PK) analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7766
Tmax was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.
Posted
Median
Full Range
hours
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Part: AUC(0-t): Area Under the Plasma Concentration From Time Zero to Last Curve for E7766
AUC was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanograms per milliliter (h*ng/mL)
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
AUC(0-inf): Area Under the Plasma Concentration From Time Zero to Infinity Curve for E7766
AUC(0-inf) was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
t1/2: Terminal Elimination Half-life for E7766
t1/2 was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7766
CL/F was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour (L/h)
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Secondary
Dose Escalation Part: Vd/F: Apparent Volume of Distribution for E7766
Vd/F was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Secondary
Dose Escalation Part: CLr: Renal Clearance for E7766
CLr was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour (L/h)
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Secondary
Dose Escalation Part: Rac (Cmax): Accumulation Ratio Based on Cmax for E7766
Rac (Cmax) was calculated as the ratio of Cmax on Cycle 1 Day 15 divided by Cmax on Cycle 1 Day 1. Accumulation ratio was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: Rac (AUC0-t): Accumulation Ratio Based on AUC for E7766
Rac (AUC0-t) was calculated as the ratio of AUC(0-t) on Cycle 1 Day 15 divided by AUC(0-t) on Cycle 1 Day 1. Accumulation ratio was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: Percentage (Fraction) Excreted (fe) in Urine for E7766
fe was defined as fraction of administered drug (E7766) excreted/recovered in urine. fe was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
percentage of dose
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Dose Escalation Part: Percentage (Fraction) Excreted (fe) in Feces for E7766
fe was defined as fraction of administered drug (E7766) excreted/recovered in feces. fe was quantified using validated liquid LC-MS/MS methods.
The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. As planned, this outcome measure was assessed in dose escalation part only. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
percentage of dose
Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Progression Free Survival (PFS) Based on mRECIST v1.1
PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on mRECIST v1.1 as per investigator assessment. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
Median
95% Confidence Interval
months
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
PFS Based on iRECIST
PFS was defined as the time from the first dose date to the date of iPD or date of death (whichever occurred first) according to iRECIST version 1.1 as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
Median
95% Confidence Interval
months
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Secondary
Overall Survival (OS)
OS was measured from the date of first dose of study drug until date of death from any cause. OS event was defined as deaths no later than data cut off date or date of death of a participant.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
Median
Full Range
months
From first dose of study drug until confirmed PD or death up to 6 months 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Dose Escalation Part: E7766 300 mcg
Secondary
Percent Change From Baseline in Tumor Size
Percent change from baseline in tumor size was calculated for the first injected lesion based on Investigator Assessment.
The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.
Posted
Mean
Standard Deviation
percent change
Baseline to up to 6 months and 18 days (Dose Escalation Part) and up to 29 months (Dose Expansion Part)
ID
Title
Description
OG000
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Dose Escalation Part: E7766 300 mcg
Time Frame
Dose Escalation Part: From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)
Description
The safety data was collected for Dose Escalation Part of the study only as no participants were enrolled in the Dose Expansion part of E7766. Hence, no data collection and analysis were done during Dose Expansion part of this study.
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
Dose Escalation Part: E7766 75 mcg
Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
1
2
0
2
2
2
EG001
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
1
2
0
2
2
2
EG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
1
2
1
2
2
2
EG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
4
11
3
11
11
11
EG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
5
6
3
6
6
6
EG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
1
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0032 events1 affected11 at risk
EG004
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site pain
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Localised oedema
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cerebral venous sinus thrombosis
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0027 events1 affected2 at risk
EG00313 events6 affected11 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected1 at risk
Anaemia of malignant disease
Blood and lymphatic system disorders
MedDRA version 25.0
Systematic Assessment
EG0002 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected2 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events2 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events2 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Oesophageal stent stenosis
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Chills
General disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0013 events1 affected2 at risk
EG0024 events1 affected2 at risk
EG003
Discomfort
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site erythema
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site oedema
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site pain
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site reaction
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Localised oedema
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Malaise
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0012 events1 affected2 at risk
EG00210 events1 affected2 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Injection site abscess
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Injection site infection
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Eschar
Injury, poisoning and procedural complications
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Amylase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
International normalised ratio increased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events2 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0005 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 25.0
Systematic Assessment
EG0002 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 25.0
Systematic Assessment
EG0001 events1 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA version 25.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
The study was terminated earlier due to corporate strategic decision, which is unrelated to safety. In addition, there is no clinical activity data that informed the decision. Therefore, no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
BG00561.0± NAStandard deviation could not be estimated as there is only one participant in this arm.
BG00658.5± 13.44
1
BG0034
BG0043
BG0050
BG00610
Male
BG0001
BG0011
BG0021
BG0037
BG0043
BG0051
BG00614
0
BG0030
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG0002
BG0012
BG0022
BG00310
BG0045
BG0051
BG00622
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0041
BG0050
BG0062
0
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
White
BG0002
BG0012
BG0022
BG00310
BG0046
BG0051
BG00623
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
11
OG0046
OG0050
2
OG0041
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
Counts
Participants
OG0000
OG0000
Units
Counts
Participants
OG0000
OG000
0
Units
Counts
Participants
OG0000
OG0000
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Dose Escalation Part: E7766 150 mcg
Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG0010.0
OG00250.0
OG00336.4
OG00416.7
OG0050.0
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG0010.0
OG00250.0
OG00336.4
OG00416.7
OG0050.0
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Dose identified from dose escalation part for E7766 was planned be used in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0004.23± 87.4
OG0012.77± 7.16
OG0022.95± 9.85
OG003
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG00311
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Dose identified from dose escalation part for E7766 was planned be used in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0000.275(0.25 to 0.3)
OG0010.31(0.27 to 0.35)
OG0020.275(0.25 to 0.3)
OG003
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG00311
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Dose identified from dose escalation part for E7766 was planned be used in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0002.71± 114.0
OG0013.42± 64.7
OG0024.25± 26.6
OG003
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG00311
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Dose identified from dose escalation part for E7766 was planned be used in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0000
OG0012
OG0022
OG0039
OG0044
OG0051
OG0060
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0039
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0015.58± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0024.64± 25.1
OG0038.07± 38.5
OG004
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Dose identified from dose escalation part for E7766 was planned be used in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0000
OG0012
OG0022
OG0039
OG0044
OG0051
OG0060
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0039
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0011.56± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0021.07± 4.61
OG0031.18± 36.9
OG004
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0000
OG0012
OG0022
OG0039
OG0044
OG0051
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0039
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG00126.9± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG00264.6± 25.2
OG00374.4± 38.5
OG004
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0000
OG0012
OG0022
OG0039
OG0044
OG0051
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0039
ParticipantsOG0043
ParticipantsOG0051
Title
Measurements
OG00160.4± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG002100.0± 29.5
OG003127.0± 65.9
OG004
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0051
Title
Measurements
OG0000.0218± 76.3
OG0010.0119± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0020.0304± 14.0
OG003
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00311
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG00311
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG0000.305± 126.0
OG0010.805± 67.4
OG0021.43± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0030.339± 117.0
OG0040.892± 10.4
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG00311
OG0044
OG0050
Title
Denominators
Categories
Title
Measurements
OG0000.198± 149.0
OG0010.571± 30.9
OG0021.08± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0030.527± 127.0
OG0040.907± 17.2
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG00311
OG0046
OG0051
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0051
Title
Measurements
OG0000.0786± 340.0
OG0010.0412± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0020.0429± 12.2
OG003
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00311
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Units
Counts
Participants
OG0002
OG0011
OG0020
OG0031
OG0042
OG0051
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0000.759± 390.0
OG0010.573± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0030.0323± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG004
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% confidence interval (CI) could not be estimated due to insufficient events.
OG001NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG002NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG003NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG004NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG005NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG002
Dose Escalation Part: E7766 300 mcg
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG001NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG002NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG003NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG004NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
OG005NA(NA to NA)Median and 95% CI could not be estimated due to insufficient events.
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range could not be estimated due to insufficient events.
OG001NA(NA to NA)Median and full range could not be estimated due to insufficient events.
OG002NA(NA to NA)Median and full range could not be estimated due to insufficient events.
OG003NA(NA to NA)Median and full range could not be estimated due to insufficient events.
OG004NA(NA to NA)Median and full range could not be estimated due to insufficient events.
OG005NA(NA to NA)Median and full range could not be estimated due to insufficient events.
Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG003
Dose Escalation Part: E7766 600 mcg
Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG004
Dose Escalation Part: E7766 780 mcg
Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG005
Dose Escalation Part: E7766 1000 mcg
Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
OG006
Dose Expansion Part
Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG00311
OG0046
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA± NAMean and standard deviation could not be estimated due to insufficient events.
OG001NA± NAMean and standard deviation could not be estimated due to insufficient events.
OG002NA± NAMean and standard deviation could not be estimated due to insufficient events.
OG003NA± NAMean and standard deviation could not be estimated due to insufficient events.
OG004NA± NAMean and standard deviation could not be estimated due to insufficient events.
OG005NA± NAMean and standard deviation could not be estimated due to insufficient events.
0 events
0 affected
6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
6 events
3 affected
11 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
3 events
1 affected
11 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0044 events2 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
5 events
5 affected
11 at risk
EG0043 events2 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
4 events
3 affected
11 at risk
EG0045 events2 affected6 at risk
EG0050 events0 affected1 at risk
27 events
9 affected
11 at risk
EG00413 events5 affected6 at risk
EG0051 events1 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
11 events
5 affected
11 at risk
EG00411 events5 affected6 at risk
EG0051 events1 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
5 events
2 affected
11 at risk
EG00410 events2 affected6 at risk
EG0051 events1 affected1 at risk
2 events
2 affected
11 at risk
EG0043 events2 affected6 at risk
EG0051 events1 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
6 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
35 events
8 affected
11 at risk
EG00419 events5 affected6 at risk
EG0051 events1 affected1 at risk
8 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
3 events
3 affected
11 at risk
EG0044 events3 affected6 at risk
EG0051 events1 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0042 events2 affected6 at risk
EG0051 events1 affected1 at risk
5 events
4 affected
11 at risk
EG0043 events2 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
7 events
5 affected
11 at risk
EG0045 events2 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
4 events
3 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
4 events
4 affected
11 at risk
EG0045 events2 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
3 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
4 events
2 affected
11 at risk
EG0044 events4 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected1 at risk
2 events
1 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
2 events
2 affected
11 at risk
EG0042 events1 affected6 at risk
EG0050 events0 affected1 at risk
4 events
3 affected
11 at risk
EG0044 events2 affected6 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
8.03
± 95.8
OG00411.3± 30.6
OG0059.99± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
6
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0001.29± 22.7
OG0012.23± 58.1
OG0024.53± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0032.72± 168
OG0049.33± 34.8
0.25
(0.2 to 0.52)
OG0040.25(0.2 to 0.28)
OG0050.28(0.28 to 0.28)
Participants
OG004
4
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0000.215(0.18 to 0.25)
OG0010.385(0.27 to 0.5)
OG0020.25(0.25 to 0.25)
OG0030.25(0.17 to 23.4)
OG0040.21(0.2 to 0.25)
7.7
± 35.9
OG0048.29± 44.2
OG00510.3± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0000.536± 17.0
OG0011.95± 29.4
OG0025.51± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0034.06± 101.0
OG0046.89± 76.9
8.93
± 54.9
OG00510.4± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0012.18± 35.4
OG0025.79± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0035.16± 83.6
OG0047.07± 75.7
1.15
± 17.5
OG0051± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0010.956± 58.1
OG0020.917± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0031.34± 66.7
OG0040.723± 59.5
87.3
± 54.8
OG00590.3± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
Title
Measurements
OG00168.7± 35.3
OG00251.8± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG003116.0± 83.7
OG004110.0± 75.9
145.0
± 50.5
OG005131.0± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
Title
Measurements
OG00194.8± 20.0
OG00268.6± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG003225.0± 80.0
OG004115.0± 40.8
0.0727
± 1030.0
OG0040.0474± 54.2
OG0050.0256± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
Title
Measurements
OG0000.0287± 617.0
OG0010.243± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0020.164± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0030.412± 320.0
OG0040.0742± 72.9
0.0935
± 799.0
OG0040.0504± 41.8
OG0050.0279± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
Participants
OG004
4
ParticipantsOG0050
Title
Measurements
OG0000.0205± 874.0
OG0010.386± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0020.302± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.
OG0030.279± 167.0
OG0040.0655± 30.8
0.0274
± 85.5
OG0050.0963± NAGeometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.