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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06049030
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Yun Chen
Phone +86 18652105250
Email cheny22@hspharm.com
Status Not yet recruiting
Phase Phase 1
Start date September 25, 2023
Completion date September 25, 2025

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