Phase 1 Study of Subcutaneous Trastuzumab Deruxtecan for Adults With Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating subcutaneous Trastuzumab Deruxtecan T-DXd in adults with metastatic solid tumors to assess its safety, tolerability, pharmacokinetics, and effectiveness. This Phase 1 trial includes participants with specific types of breast cancer and non-small cell lung cancer with HER2 mutations, focusing on those who have received prior therapies and have measurable disease progression. Participants will be assigned to one of two parts the dose escalation phase, where they receive increasing doses of T-DXd to determine the recommended dose for expansion RDE, and the dose expansion phase, where participants receive T-DXd at the RDE. The drug is administered subcutaneously, and dosing will be guided by safety and response data collected during the trial. During the study, participants will be monitored for treatment-emergent adverse events, dose-limiting toxicities, and drug levels in their bodies over approximately 9 months. Researchers will also evaluate immune responses and tumor control rates up to 12 months. Assessments include imaging, safety labs, and clinical evaluations to track disease status and side effects, with the study lasting until the primary completion date in late 2028.

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors