Trials / Unknown
UnknownNCT06049030
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
A Phase Ia/Ib Study of HS-10516 to Investigate the Safety, Tolerance, Pharmacokinetic and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 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 ccRCC.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HS-10516 | Oral HIF-2α inhibitor |
Timeline
- Start date
- 2023-09-25
- Primary completion
- 2024-09-25
- Completion
- 2025-09-25
- First posted
- 2023-09-21
- Last updated
- 2023-09-26
Source: ClinicalTrials.gov record NCT06049030. Inclusion in this directory is not an endorsement.