Spots Global Cancer Trial Database for A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma

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Trial Identification

Brief Title: A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma

Official Title: A Phase Ia/Ib Study of HS-10516 to Investigate the Safety, Tolerance, Pharmacokinetic and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma

Study ID: NCT06049030

Conditions

Renal Cell Carcinoma

Interventions

HS-10516

Study Description

Brief Summary: The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in ccRCC.

Detailed Description: This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with advanced clear cell renal cell carcinoma who have failed or are unavailable/intolerant to standard of care. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.