Daiichi Sankyo
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.
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…
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE. Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.