First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors
brief summary
This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.
detailed description
This is a global, multicenter, open-label, first-in human (FIH), dose escalation trial for participants with advanced, metastatic, or unresectable solid tumors. The primary objectives of the trial are to evaluate the safety and tolerability of DS1025a in solid tumors participants and to determine the recommended dose for expansion (RDE). RDE determination will be based on the totality of the data, including safety, efficacy, PK/PD, and biomarkers. The primary endpoints of the trial are DLTs, AEs, and DS1025a discontinuation due to AEs. Secondary and exploratory objectives are to evaluate efficacy, PK, and PD of DS1025a.
official title
A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors