Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1/2, Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
The study will be conducted in the United States of America (USA) and China to provide safety, efficacy and PK data from these regions. A dose escalation part 1 will be conducted to determine the MTD, DLT's, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-15293 given once daily, in patients with advanced NSCLC to obtain preliminary efficacy information. PK samplings at Cycle 1, Day 1 and at steady-state conditions (Cycle 1, Day 28) will be performed. PD evaluations will occur at cycle 1 and cycle 2. ;
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