A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Daiichi Sankyo
Summary
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Adults ≥18 years or the minimum legal adult age (whichever is greater). 2. a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available. Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either: * the metastatic setting, or * the neoadjuvant or adjuvant setting and have de…