Spots Global Cancer Trial Database for A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors
Official Title: A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10381 in Patients With Advanced Solid Tumors
Study ID: NCT05378178
Conditions
Interventions
Study Description
Brief Summary: HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors.
Detailed Description: This is a Phase 1 open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary efficacy of HS-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
West China Hospital of Sichuan University, Xi'an, Sichuan, China
Contact Details
Name: You Lu
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR
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