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Brief Title: Phase 1/2 Study of HS-10370 in Patients With Advanced Solid Tumors
Official Title: A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10370 Monotherapy in Patients With Advanced Solid Tumors
Study ID: NCT05367778
Brief Summary: HS-10370 is an oral, highly selective, small molecular inhibitor of KRAS G12C. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10370 in Chinese advanced solid tumor patients.
Detailed Description: This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10370, this study has two parts: phase 1 and phase 2. The phase 1 portion consists of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10370 in subjects with advanced solid tumors and evaluate the preliminary efficacy of HS-10370. Phase 2 will be conducted to evaluate the efficacy of HS-10370 in subjects with locally advanced or metastatic NSCLC with a KRAS G12C mutation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology, Wuhan, Hubei, China
Name: Xiaorong Dong, PhD
Affiliation: Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR