Actively Recruiting
Phase 1 Study of DS3610a for Adults With Advanced or Metastatic Solid Tumors Evaluating Safety, Dose, and Effects of DS3610a Treatment
Led by Daiichi Sankyo · Updated on 2025-12-10
70
Participants Needed
2
Research Sites
126 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to assess the safety, tolerability, and initial effectiveness of DS3610a in adults with advanced or metastatic solid tumors. The study is a phase 1, open-label trial focusing on determining the recommended dose for further expansion, while also evaluating how the drug behaves in the body and its preliminary benefits. Participants have solid tumors that have progressed despite prior treatments or who cannot tolerate standard therapies. Participants will receive DS3610a at increasing doses to find the optimal dose level. Treatment continues until the tumor shows progression on imaging or another reason requires stopping. This dose escalation phase collects data to set the recommended dose for future studies, monitoring participants closely throughout. The study does not include a placebo group and is non-randomized. During the trial, participants will undergo assessments including scans to measure tumor size, blood tests to monitor drug levels and immune responses, and evaluations for side effects. The primary outcome is monitoring dose-limiting toxicities for up to 24 months, with additional measures over 36 months. Participation involves regular visits for treatment and safety checks, lasting as long as treatment continues or until disease progression occurs.
CONDITIONS
Brief Title
A Study of DS3610a in Participants With Advanced Solid Tumor
Research Team
C
Contact for Trial Information
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