Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
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ClinicalTrials.gov Identifier: NCT02564900 |
Recruitment Status :
Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : August 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors | Drug: DS-8201a | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 278 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2015 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | March 2020 |
Arm | Intervention/treatment |
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Experimental: Part 1 Dose escalation
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.
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Drug: DS-8201a |
Experimental: Part 2 Dose expansion
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), and HER2 expressing other solid malignant tumor (Part 2d)
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Drug: DS-8201a |
- Number of subjects experiencing adverse events [ Time Frame: Day 1 through 28 days after last dose ]frequency and seriousness of treatment emergent adverse events (TEAEs).
- Tumor response using RECIST version 1.1 throughout study [ Time Frame: from randomization date until disease progresses, whichever comes first, up to 30 months ]RECIST = Response Evaluation Criteria In Solid Tumors Assessment of tumor response is conducted every 6 weeks in the first 24 weeks and thereafter every 12 weeks until progressive disease to evaluate the efficacy of DS-8201a up to 30 months.
- Change in the area under curve (AUC) of DS-8201a [ Time Frame: from first dose to Day 45 ]area under curve AUC at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the maximum plasma concentration (Cmax) of DS-8201a [ Time Frame: from first dose to Day 45 ]maximum plasma concentration Cmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the time of maximum plasma concentration (Tmax) of DS-8201a [ Time Frame: from first dose to Day 45 ]time of maximum plasma concentration Tmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the total anti-HER2 antibody [ Time Frame: from first dose to Day 45 ]Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in MAAA-1181 level [ Time Frame: from first dose to Day 45 ]determine the change in MAAA-1181 level from first dose to Day 45 at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564900
United States, California | |
Sharp Memorial Hospital | |
San Diego, California, United States, 92123 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Ohio | |
UC Health Clinical Trials Office | |
Cincinnati, Ohio, United States, 45229 | |
United States, Texas | |
University of Texas M. D. Anderson Cancer Center | |
Houston, Texas, United States, 77030-3721 | |
Japan | |
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 |
Study Director: | Global Clinical Leader | Daiichi Sankyo, Inc. |
Responsible Party: | Daiichi Sankyo Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02564900 |
Other Study ID Numbers: |
DS8201-A-J101 152978 ( Registry Identifier: JAPIC CTI ) |
First Posted: | October 1, 2015 Key Record Dates |
Last Update Posted: | August 9, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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/ |
Supporting Materials: |
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. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Advanced solid tumors phase 1 oncology HER2 Antibody drug conjugate (ADC) |
Neoplasms |