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Brief Title: Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
Official Title: An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation
Study ID: NCT06243354
Brief Summary: This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Hunan Provincial Cancer Hospital, Changsha, Hunan, China
The first Hospital of China Medical University, Shenyang, Liaoning, China
Shandong Provincial Cancer Hospital, Jinan, Shandong, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China