Advanced Solid Tumors Clinical Trial
Official title:
A Multi-Center, Open-Label, Phase Ib/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w）.
Part 1 (Phase Ib): This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. One cycle is 21 days. Part 2 (Phase II): This is an expansion phase in patients with advantage advanced solid tumors to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D combined with Sintilimab. ;
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|---|---|---|---|
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