A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Daiichi Sankyo
Summary
This is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Sign and date the ICF, prior to the start of any trial- specific qualification procedures. 2. Adults ≥18 years or the minimum legal adult age (whichever is greater). 3. a) Disease State: If HER2 status is required for eligibility (for all populations, except "Pan-tumor, heavily pretreated, with no SoC"), a documented HER2 test result must be available. A participant population would only be considered in regions where T-DXd is approved for that indication and an approved or validated test is available, if required per country regulations. Note: for all indications,…