Clinical Trial

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

Recruiting Phase 1/2
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Summary
This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-12-15; most recent amendment 2026-07-08.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06741644
Lead Sponsor CStone Pharmaceuticals
Conditions Advanced Solid Tumors
Enrollment 660 participants
Start Date 2025-02-24
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-09