NCT07097935

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will commence with a dose exploration phase employing a safety lead-in approach. Treatment cycles are set at 28 days, with investigational product administration continuing until disease progression or meeting other treatment discontinuation criteria. Each dose level will enroll 3-6 participants for dose-limiting toxicity (DLT) assessment to evaluate the tolerability, safety, and PK/PD profiles of HS-10516 combined with lenvatinib. The Safety Review Committee (SRC) will determine subsequent dose levels for exploration through joint deliberation. If all predefined dose levels prove intolerable, the SRC may authorize exploration of lower dose levels. Additionally, PK expansion cohorts (up to 12 participants per cohort) may be implemented in suitable dose levels. Following identification of safe dose levels in the exploration phase, 1-2 dose cohorts will advance to the proof-of-concept phase, with each cohort enrolling up to 40 participants to further assess therapeutic efficacy and safety.

Conditions

• Advanced Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HS-10516 + Lenvatinib	Administered orally.

Timeline

• Start date: 2025-07-10
• Primary completion: 2027-07-10
• Completion: 2028-07-10
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: China