Actively Recruiting
An Open-Label Phase 1/2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
Led by Zhejiang Haichang Biotech Co., Ltd. · Updated on 2026-03-19
60
Participants Needed
4
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the maximum tolerated dose of WGI-0301 combined with Sorafenib for adults with advanced hepatocellular carcinoma (HCC) who have previously received PD-1 or PD-L1 immune checkpoint inhibitors. This phase 2 study aims to assess the safety and effectiveness of this combination treatment in patients with advanced, unresectable HCC. The study includes patients with specific stages of HCC who have failed or cannot tolerate standard treatments. The study has two stages: Stage 1 involves dose escalation to determine the recommended dose of WGI-0301 when combined with Sorafenib. Stage 2 compares two different doses of WGI-0301 plus standard Sorafenib against Sorafenib alone. WGI-0301 is given by intravenous infusion weekly, while Sorafenib is taken orally twice daily. Participants receive these treatments according to their assigned group during the study. Participants will undergo regular assessments including imaging scans to measure tumor response using RECIST 1.1 criteria, safety and tolerability evaluations, and biomarker testing through tissue samples. Researchers will monitor anti-tumor activity, progression-free survival, overall survival, and treatment side effects over an average of two years. The study also includes careful monitoring of organ function and patient health throughout the trial period.
CONDITIONS
Brief Title
Phase 2 Study of WGI-0301 for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, male or female
- Willing and able to provide signed informed consent and comply with study protocol
- Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC)
- BCLC Stage C or Stage B with bilobar involvement suitable only for systemic therapy
- First-line standard treatment failure or intolerance as defined for each study stage
- Eligible for Sorafenib treatment as judged by investigators
- ECOG performance status of 0 or 1 within 7 days before first dose
- At least one measurable lesion by RECIST 1.1 not previously targeted by local therapy
- Life expectancy greater than 12 weeks
- Recovery to Grade 1 or better from prior treatment toxicities
- Collection of tissue sample for biomarker testing if possible
- Adequate organ function including Child-Pugh Class A or B (score ≤7), liver enzymes, bilirubin, albumin, kidney function, coagulation, and blood counts
- Patients with HBV or HCV infection meeting specific viral load and treatment criteria
- Women of childbearing potential must have negative pregnancy test and use effective contraception; men must use contraception during and after study participation
You will not qualify if you...
- Pregnant or breastfeeding, or planning to conceive or father children during the study
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma (Stage 2 and 3)
- Complete blockage of major portal vein or vena cava by tumor
- Major surgery within 4 weeks before first dose
- Known allergy to WGI-0301, Sorafenib, or related drugs
- Prior Sorafenib or AKT-PI3K pathway targeting therapy (Stage 3 only)
- Participation in other investigational studies within 4 weeks
- Recent locoregional liver therapies or antitumor treatments within specified timeframes
- Use of strong CYP3A4 inducers (Stage 2 and 3) within 12 days
- Significant glucose metabolism disorders including treated diabetes or HbA1c ≥8.0%
- Significant cardiovascular conditions or uncontrolled blood pressure
- Clinically significant gastrointestinal disorders or bleeding risks
- History of solid organ transplant
- Known HIV/AIDS or recent immunosuppressive therapy
- Active uncontrolled infections
- Uncontrolled fluid buildup requiring repeated drainage
- Other cancers except some treated skin or cervical cancers with no disease for 3 years
- Untreated or symptomatic brain metastases
- Current drug abuse or addiction
- Any condition that would interfere with participation or increase risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive WGI-0301 in combination with Sorafenib or Sorafenib alone as second-line therapy for advanced hepatocellular carcinoma.
Weekly visits for drug infusions and continuous oral medication
Duration - Up to 2 years after treatment ends
Participants are monitored for safety, tolerability, and anti-tumor activity after completing treatment.
Regular visits depending on study completion schedule
Trial Site Locations
Total: 4 locations
1
China Pharmaceutical University, Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
2
West China Hospital Sichuan University
Chengdu, China
Actively Recruiting
3
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
4
Prince of Wales Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
A
Angela Men, MD., Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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