DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

• Status: Completed
• Trial end date: 2020-11-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborators: AstraZeneca; Daiichi Sankyo, Inc.
• Treatments: Trastuzumab

Criteria

Inclusion 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

Exclusion Criteria:

• 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