Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC
NCT07540832 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-04-20
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 Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.
Conditions
- Advanced Hepatocellular Carcinoma (HCC)
Interventions
- DRUG
-
WGI-0301
WGI-0301 at Maximum Tolerated Dose (MTD)
- DRUG
-
WGI-0301
WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)
- DRUG
-
Lenvatinb
Lenvatinib for patients with body weight of \<60 kg: 8 mg orally daily, for patients with body weight ≥60 kg: 12 mg orally daily
Sponsors & Collaborators
-
Zhejiang Haichang Biotech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-09-30
- Completion
- 2028-10-31
- FDA Drug
- Yes
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