drugset / Trial / NCT07097935

Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma

NCT07097935

Phase 1/2 Recruiting 104 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
NaSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label, Phase Ib/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one prior line of systemic therapy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.

Timeline

Start
2025-07-10
Primary completion
2027-07-10
Completion
2028-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10516 Unknown Oral
Background Lenvatinib Small molecule Oral