NCT06553339

A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors

A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 patients with VHL Syndrome Associated Tumors.

Detailed description

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. 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.

Conditions

• Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Oral HS-10516	Oral HIF-2α inhibitor

Timeline

• Start date: 2024-07-19
• Primary completion: 2026-07-31
• Completion: 2028-07-31
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: China