Study of DS-8201a in Subjects With Advanced Solid Maligna... | NCT02564900 | Trialant
NCT02564900
Sponsor
Daiichi Sankyo Co., Ltd.
Status
Completed
Last Update Posted
Jan 22, 2024Actual
Enrollment
292Actual
Phase
Phase 1
Conditions
Advanced Solid Tumors
Interventions
DS-8201a (DP1)
DS-8201a (DP2)
DS-8201a (DP)
Countries
United States
Japan
Protocol Section
Identification Module
NCT ID
NCT02564900
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DS8201-A-J101
Secondary IDs
ID
Type
Description
Link
152978
Registry Identifier
JAPIC CTI
Brief Title
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Official Title
Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors
Acronym
Not provided
Organization
Daiichi SankyoINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 1, 2015Actual
Primary Completion Date
Feb 1, 2019Actual
Completion Date
Dec 22, 2023Actual
First Submitted Date
Sep 21, 2015
First Submission Date that Met QC Criteria
Sep 29, 2015
First Posted Date
Oct 1, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 14, 2020
Results First Submitted that Met QC Criteria
Jun 1, 2021
Results First Posted Date
Jun 23, 2021Actual
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
Jan 18, 2024
Last Update Posted Date
Jan 22, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Daiichi Sankyo Co., Ltd.INDUSTRY
Collaborators
Name
Class
Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumors
Keywords
Advanced solid tumors
phase 1
oncology
HER2
Antibody drug conjugate (ADC)
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
292Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Dose escalation
Experimental
Part 1 is a dose escalation to identify the Maximum Tolerated dose (MTD) or the recommended phase 2 dose of DS-8201a guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation with overdose control principal.
Drug: DS-8201a (DP1)
Drug: DS-8201a (DP)
Part 2 Dose expansion
Experimental
Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part 2c), HER2 expressing other solid malignant tumor (Part 2d); HER2 expressing breast cancer (Japan only; Part 2e)
Drug: DS-8201a (DP1)
Drug: DS-8201a (DP2)
Drug: DS-8201a (DP)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DS-8201a (DP1)
Drug
DS-8201a to be administered via intravenous (IV) dose. DS-8201a (DP1) was used for the Dose Escalation phase and for Dose expansion Parts 2a, 2b, 2c, and 2d.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
From 6 months postdose of last participant up to 3 years 5 months
Secondary Outcomes
Measure
Description
Time Frame
Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.
Left Ventricular Ejection Fraction (LVEF) ≥ 50%
Part 1:
Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2a:
Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Treated with ado-trastuzumab emtansine (T-DM1)
Part 2b:
Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Treated with trastuzumab
Part 2c:
Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2d:
Satisfy at least one of the following criteria
Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2e:
Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
Exclusion Criteria:
Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
Has a medical history of myocardial infarction or unstable angina.
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
Has a medical history of clinically significant lung diseases
Tsurutani J, Iwata H, Krop I, Janne PA, Doi T, Takahashi S, Park H, Redfern C, Tamura K, Wise-Draper TM, Saito K, Sugihara M, Singh J, Jikoh T, Gallant G, Li BT. Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors. Cancer Discov. 2020 May;10(5):688-701. doi: 10.1158/2159-8290.CD-19-1014. Epub 2020 Mar 25.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of DS-8201a with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, doses of 5.4 mg/kg and 6.4 mg/kg were chosen for evaluation in the Dose Expansion phase.
Recruitment Details
A total of 292 participants who met all inclusion and no exclusion criteria were enrolled at 8 centers in the US and 6 centers in Japan. A total of 27 participants started the Dose Escalation phase and a total of 265 participants in the Dose Expansion phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
FG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Periods
Title
Milestones
Reasons Not Completed
Dose Escalation
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
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Apr 26, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part 1 Dose escalation
Part 2 Dose expansion
DS-8201a (DP2)
Drug
DS-8201a is to be administered via intravenous (IV) dose. DS-8201a (DP2) was used only used for Dose Expansion Part 2e.
Part 2 Dose expansion
DS-8201a (DP)
Drug
DS-8201a (DP) is to be administered via intravenous (IV) dose.
Part 1 Dose escalation
Part 2 Dose expansion
From 6 months postdose of last participant up to 3 years 5 months
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Best overall response by independent central review was defined as the proportion of participants who achieved either complete response [CR], partial response [PR], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
From 6 months postdose of last participant up to 3 years 5 months
Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Duration of response (DoR) by independent central review was defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
From 6 months postdose of last participant up to 3 years 5 months
Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Time to response (TTR) by independent central review was defined as the time interval between the date of registration until the date at which the criteria were first met for complete response (CR) or partial response (PR). Only participants who achieved CR or PR were included in the TTR analysis. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
From 6 months postdose of last participant up to 3 years 5 months
Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
From 6 months postdose of last participant up to 3 years 5 months
Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Overall survival (OS) by independent central review was defined as the time interval from the date of enrollment to the date of death from any cause. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
From 6 months postdose of last participant up to 3 years 5 months
Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Post first dose up to Day 147
Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose
The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
Post first dose up to Day 147
Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose
The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.
Post first dose up to Day 147
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose
The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was estimated using standard non-compartmental methods.
Post first dose up to Day 147
Overview of Treatment-emergent Adverse Events
Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months
Jacksonville
Florida
32224
United States
University of Louisville
Louisville
Kentucky
40202
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
UC Health Clinical Trials Office
Cincinnati
Ohio
45229
United States
University of Texas M. D. Anderson Cancer Center
Houston
Texas
77030-3721
United States
Aichi Cancer Center Hospital
Aichi
Japan
National Cancer Center Hospital East
Chiba
Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima
Japan
Kindai University Hospital
Osaka
Japan
National Cancer Center Hospital
Tokyo
Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo
Japan
Result
Tamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, Sagara Y, Doi T, Park H, Murthy RK, Redman RA, Jikoh T, Lee C, Sugihara M, Shahidi J, Yver A, Modi S. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019 Jun;20(6):816-826. doi: 10.1016/S1470-2045(19)30097-X. Epub 2019 Apr 29.
Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.
Doi T, Shitara K, Naito Y, Shimomura A, Fujiwara Y, Yonemori K, Shimizu C, Shimoi T, Kuboki Y, Matsubara N, Kitano A, Jikoh T, Lee C, Fujisaki Y, Ogitani Y, Yver A, Tamura K. Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody-drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study. Lancet Oncol. 2017 Nov;18(11):1512-1522. doi: 10.1016/S1470-2045(17)30604-6. Epub 2017 Oct 13.
Takahashi S, Bando H, Kinoshita I, Modi S, Tsurutani J, Bang YJ, Sato Y, Nakatani S, Lee C, Sugihara M, Okuda Y, Iwata H. Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies. Jpn J Clin Oncol. 2024 Apr 6;54(4):434-443. doi: 10.1093/jjco/hyad181.
Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.
Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol. 2020 Jun 10;38(17):1887-1896. doi: 10.1200/JCO.19.02318. Epub 2020 Feb 14.
FG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
FG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
FG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
FG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
FG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
FG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
FG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG012
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG013
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG014
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
Data from Ongoing and Discontinued participants are presented as of data cutoff on 01 February 2019
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Progressive disease per RECIST
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Ongoing
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Dose Expansion
Type
Comment
Milestone Data
STARTED
Only the Dose Expansion Phase is being presented.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00649 subjects
FG00762 subjects
FG00820 subjects
FG00933 subjects
FG01017 subjects
FG01124 subjects
FG01218 subjects
FG01320 subjects
FG01422 subjects
Enrolled, But Not Dosed
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
Data from Ongoing and Discontinued participants are presented as of data cutoff on 01 February 2019.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Progressive disease per RECIST
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Demographic and baseline characteristics were assessed in the Enrolled Analysis Set (Dose Escalation, n=27; Dose Expansion, n=265).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
BG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
BG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
BG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
BG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
BG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
BG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
BG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
BG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG012
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG013
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG014
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0036
BG0046
BG0056
BG00649
BG00762
BG00820
BG00933
BG01017
BG01124
BG01218
BG01320
BG01422
BG015292
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.3± 7.09
BG00166.3± 4.73
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
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
Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
ORR was assessed among participants in the Intent-to-Treat Analysis Set.
Posted
Number
95% Confidence Interval
percentage of participants
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 70.8)
OG00133.3(0.8 to 90.6)
OG0020(0 to 70.8)
OG003
Secondary
Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
DCR was assessed in the Intent-to-Treat Analysis Set.
Posted
Number
95% Confidence Interval
percentage of participants
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Secondary
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Best overall response by independent central review was defined as the proportion of participants who achieved either complete response [CR], partial response [PR], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Best overall response was assessed in the Intent-to-Treat Analysis Set.
Posted
Count of Participants
Participants
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Secondary
Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Duration of response (DoR) by independent central review was defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
DoR was assessed among participants who achieved a CR or PR in the Intent-to-Treat Analysis Set.
Posted
Median
95% Confidence Interval
months
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Secondary
Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Time to response (TTR) by independent central review was defined as the time interval between the date of registration until the date at which the criteria were first met for complete response (CR) or partial response (PR). Only participants who achieved CR or PR were included in the TTR analysis. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time to response was assessed among participants who achieved CR or PR in the Intent-to-Treat Analysis Set.
Posted
Median
95% Confidence Interval
months
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Secondary
Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
PFS was assessed in the Intent-to-Treat Analysis Set.
Posted
Median
95% Confidence Interval
months
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Secondary
Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Overall survival (OS) by independent central review was defined as the time interval from the date of enrollment to the date of death from any cause. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
OS was assessed in the Intent-to-Treat Analysis Set.
Posted
Median
95% Confidence Interval
months
From 6 months postdose of last participant up to 3 years 5 months
ID
Title
Description
OG000
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG002
Secondary
Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
ug*d/mL
Post first dose up to Day 147
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Secondary
Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose
The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
ug/mL
Post first dose up to Day 147
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Secondary
Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose
The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Median
Full Range
hours
Post first dose up to Day 147
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Secondary
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose
The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was estimated using standard non-compartmental methods.
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Posted
Mean
Standard Deviation
days
Post first dose up to Day 147
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Secondary
Overview of Treatment-emergent Adverse Events
Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.
Posted
Count of Participants
Participants
Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months
ID
Title
Description
OG000
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
OG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Time Frame
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
Description
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
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: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
0
3
0
3
3
3
EG001
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
0
3
0
3
3
3
EG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
0
3
0
3
3
3
EG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
0
6
1
6
6
6
EG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
0
6
1
6
6
6
EG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
0
6
1
6
6
6
EG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
3
50
11
50
50
50
EG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
1
66
17
66
66
66
EG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
0
21
3
21
20
21
EG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
0
33
12
33
33
33
EG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
1
19
4
19
19
19
EG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
1
25
7
25
25
25
EG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
5
59
18
59
59
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0062 affected50 at risk
EG0070 affected66 at risk
EG0080 affected21 at risk
EG0090 affected33 at risk
EG0102 affected19 at risk
EG0111 affected25 at risk
EG0120 affected59 at risk
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestine obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal mucosa hyperaemia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Scleroderma-like reaction
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disease progression
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Central venous catheterisation
Surgical and medical procedures
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0032 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0065 affected50 at risk
EG0079 affected66 at risk
EG0080 affected21 at risk
EG0094 affected33 at risk
EG0100 affected19 at risk
EG0113 affected25 at risk
EG0126 affected59 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Keratitis
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal tear
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza-like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 20.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Protein total decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infusion-related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour-associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG014
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
6
OG0046
OG0056
OG00651
OG00767
OG00821
OG00933
OG01019
OG01125
OG01218
OG01320
OG01423
83.3
(35.9 to 99.6)
OG00433.3(4.3 to 77.7)
OG00550.0(11.8 to 88.2)
OG00651.0(36.6 to 65.2)
OG00753.7(41.1 to 66.0)
OG00833.3(14.6 to 57.0)
OG00939.4(22.9 to 57.9)
OG01026.3(9.1 to 51.2)
OG01132.0(14.9 to 53.5)
OG01255.6(30.8 to 78.5)
OG0135.0(0.1 to 24.9)
OG01430.4(13.2 to 52.9)
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG014
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG00651
OG00767
OG00821
OG00933
OG01019
OG01125
OG01218
OG01320
OG01423
Title
Denominators
Categories
Title
Measurements
OG000100.0(29.2 to 100.0)
OG001100.0(29.2 to 100.0)
OG00266.7(9.4 to 99.2)
OG003100.0(54.1 to 100.0)
OG004100.0(54.1 to 100.0)
OG005100.0(54.1 to 100.0)
OG00688.2(76.1 to 95.6)
OG00795.5(87.5 to 99.1)
OG00885.7(63.7 to 97.0)
OG00987.9(71.8 to 96.6)
OG01078.9(54.4 to 93.9)
OG01188.0(68.8 to 97.5)
OG01283.3(58.6 to 96.4)
OG01380.0(56.3 to 94.3)
OG01482.6(61.2 to 95.0)
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG014
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG00651
OG00767
OG00821
OG00933
OG01019
OG01125
OG01218
OG01320
OG01423
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0062
OG0078
OG0080
OG0090
OG0100
OG0111
OG0120
OG0130
OG0142
Partial response
Title
Measurements
OG0000
OG0011
OG0020
OG003
Stable disease
Title
Measurements
OG0003
OG0012
OG0022
OG003
Progressive disease
Title
Measurements
OG0000
OG0010
OG0021
OG003
Non-evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG00051
OG00167
OG00221
OG00333
OG00419
OG00525
OG00618
OG00720
OG00823
Title
Denominators
Categories
Title
Measurements
OG00012.7(6.7 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG00113.6(7.3 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG002NA(NA to NA)Lack of a median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
OG00310.4(3.4 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG0045.6(2.9 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG0056.9(3.5 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG00610.7(6.9 to 11.5)
OG00713.4(NA to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG008NA(3.0 to NA)Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG002
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG00051
OG00167
OG00221
OG00333
OG00419
OG00525
OG00618
OG00720
OG00823
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.5 to 2.9)
OG0012.8(1.4 to 2.9)
OG0022.6(1.2 to 4.2)
OG0032.7(1.2 to 3.1)
OG0041.6(1.2 to 3.1)
OG0052.2(1.4 to 2.9)
OG0061.4(1.2 to 2.8)
OG0073.0(NA to NA)The 95% confidence interval was not calculable due to insufficient number of participants with events.
OG0081.6(1.2 to 2.9)
OG002
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG00051
OG00167
OG00221
OG00333
OG00419
OG00525
OG00618
OG00720
OG00823
Title
Denominators
Categories
Title
Measurements
OG00013.7(8.5 to 19.6)
OG00114.1(8.5 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG002NA(2.7 to NA)Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
OG00311.1(5.0 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG0044.3(2.6 to 8.6)
OG0058.2(4.2 to 11.0)
OG00611.3(7.2 to 14.3)
OG0074.0(2.7 to 5.6)
OG00811.0(2.8 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG003
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG00051
OG00167
OG00221
OG00333
OG00419
OG00525
OG00618
OG00720
OG00823
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Lack of median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
OG001NA(26.4 to NA)Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
OG002NA(NA to NA)Lack of median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
OG00319.7(12.5 to 29.4)
OG00418.9(5.7 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG00526.2(10.0 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG006NA(17.3 to NA)Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
OG00715.6(4.8 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
OG00823.4(9.7 to NA)Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Breast Cancer
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0055
OG00648
OG00750
OG00820
OG00919
OG01017
OG01123
OG01258
OG01321
Title
Denominators
Categories
AUClast
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG00648
ParticipantsOG00750
ParticipantsOG00820
ParticipantsOG00919
ParticipantsOG01017
ParticipantsOG01123
ParticipantsOG01258
ParticipantsOG01321
Title
Measurements
OG00051.7± 13.1
OG001116± 58.7
OG002325± 142
OG003
AUCinfinity
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Breast Cancer
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0055
OG00648
OG00750
OG00820
OG00919
OG01017
OG01123
OG01259
OG01321
Title
Denominators
Categories
Title
Measurements
OG00022.9± 3.76
OG00136.2± 4.98
OG00278.2± 16.1
OG003127± 17.2
OG004181± 33.1
OG005221± 41.0
OG006126± 37.7
OG007170± 53.6
OG008133± 18.3
OG009155± 33.2
OG010113± 30.0
OG011116± 21.1
OG012150± 30.3
OG013155± 21.4
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Breast Cancer
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0055
OG00648
OG00750
OG00820
OG00919
OG01017
OG01123
OG01259
OG01321
Title
Denominators
Categories
Title
Measurements
OG0001.95(1.62 to 1.98)
OG0014.03(1.87 to 4.08)
OG0024.12(1.95 to 6.88)
OG0032.02(1.87 to 2.07)
OG0042.06(1.50 to 3.97)
OG0051.97(1.70 to 6.80)
OG0062.00(1.50 to 6.85)
OG0072.08(1.53 to 7.05)
OG0082.16(1.50 to 7.07)
OG0092.00(1.50 to 6.67)
OG0102.03(1.58 to 4.08)
OG0111.95(1.53 to 7.00)
OG0122.02(1.50 to 7.20)
OG0132.05(1.62 to 7.23)
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG013
Dose Expansion: HER2-expressing Breast Cancer
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0055
OG00648
OG00749
OG00819
OG00917
OG01017
OG01122
OG01258
OG01321
Title
Denominators
Categories
Title
Measurements
OG0002.18± 0.671
OG0013.07± 1.22
OG0024.23± 1.24
OG0036.03± 0.603
OG0047.33± 1.64
OG0056.44± 0.793
OG0065.52± 1.23
OG0076.00± 1.22
OG0085.28± 1.49
OG0095.79± 1.01
OG0106.18± 1.18
OG0115.90± 1.57
OG0125.61± 1.29
OG0135.46± 1.02
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG004
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG005
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
OG006
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG007
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG008
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
OG009
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG010
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG011
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
OG012
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG00650
OG00766
OG00821
OG00933
OG01019
OG01125
OG01259
Title
Denominators
Categories
Treatment-emergent adverse events (TEAEs)
Title
Measurements
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG00650
OG00766
OG00820
OG00933
OG01019
OG01125
OG01259
Drug-related TEAEs
Title
Measurements
OG0003
OG0012
OG0022
OG003
TEAEs ≥Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Drug-related TEAEs ≥Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious TEAEs (including AEs ending in death)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Drug-related serious TEAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAEs associated with death
Title
Measurements
OG0000
OG0010
OG0020
OG003
Drug-related TEAEs associated with death
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAEs associated with discontinuation of drug
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related TEAEs associated with drug discontinuation