Trials / Not Yet Recruiting
Not Yet RecruitingNCT07494435
Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC
An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Zhejiang Haichang Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WGI-0301 | WGI-0301 at Maximum Tolerated Dose (MTD) |
| DRUG | Nivolumab (240 mg) | Nivolumab is given as an intravenous infusion, every 2 weeks |
| DRUG | WGI-0301 | WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1) |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-06-01
- Completion
- 2028-09-01
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07494435. Inclusion in this directory is not an endorsement.