RecruitingPhase 1Phase 2NCT07097935

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

A Phase Ib/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

104 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination (HS-10516 plus other treatments) for people with advanced kidney cancer (clear cell renal cell carcinoma) that has continued growing or spread despite previous treatment. Researchers want to find out if this combination is safe and effective. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic clear cell kidney cancer - Your cancer got worse during or after at least one prior treatment - You have at least one measurable tumor on scans - You are well enough to carry out daily activities (ECOG 0–1) - Your expected survival is more than 12 weeks - You are willing to use contraception during and for 12 months after treatment **You may NOT be eligible if...** - You have previously used lenvatinib or HIF inhibitors - You have active or spreading brain metastases - You have severe, uncontrolled heart disease, diabetes, or high blood pressure - Your blood oxygen level is below 92% - You have had a second primary cancer - You recently had major surgery or received other cancer therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHS-10516 + Lenvatinib

Administered orally.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07097935


Related Trials