Spots Global Cancer Trial Database for A Study of YL-17231 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of YL-17231 in Patients With Advanced Solid Tumors

Official Title: Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of Pan-KRAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors With KRAS Mutation

Study ID: NCT06078800

Conditions

Advanced Solid Tumor

Interventions

YL-17231

Study Description

Brief Summary: This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-17231 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-17231 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.

Detailed Description: The study will be conducted in China to provide safety, efficacy and PK data. A dose escalation part 1 will be conducted to determine the MTD, DLTs, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-17231 given twice daily, in patients with advanced solid tumors to obtain preliminary efficacy information. PK samplings at single dose stage Day 1 and at steady-state conditions (Cycle 1, Day 14) will be performed.