A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer
Description
Brief Summary
The main objective of this study is to test the safety and effectiveness of DS-8201a for
participants with HER2-expressing advanced colorectal cancer.
Detailed Description
At study start, only Cohort A is active.
If, and when, Cohort B and C become active depends on the assessment of benefit and risk
observed in the program.
The sponsor will inform the investigators if, and when, Cohort B and C are active.
Phase
N/AInclusion and Exclusion Criteria
- Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
- Has received at least 2 prior regimens of standard treatment
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a medical history of clinically significant lung disease
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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