Actively Recruiting
A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Led by Abivax S.A. · Updated on 2021-03-26
48
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Abivax S.A.
Lead Sponsor
C
C3 Research Associates
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacodynamic effects, and early effectiveness of ABX196 combined with nivolumab in adults with hepatocellular carcinoma, a type of liver cancer. This open-label, uncontrolled phase 1-2 study aims to explore these outcomes in patients whose cancer is not suitable for curative surgery or local therapy and who have received prior systemic treatment. The study includes two phases: a Dose Escalation Phase and an Expansion Phase. Nivolumab is given as a 30-minute intravenous infusion on Days 1 and 15 of each 28-day cycle. ABX196 is administered as an intramuscular injection about 120 minutes after the nivolumab infusion on Day 1 of every other 28-day cycle, meaning every 8 weeks. Different doses of ABX196 (0.1, 0.2, and 0.4 micrograms) are tested during the study. Participants will be monitored through regular assessments including scans to measure tumor response, blood tests such as alpha fetoprotein levels every 2 weeks, and evaluations of liver function and overall health. The main outcome measured is the incidence of adverse events over about one year. Secondary outcomes include response rates, duration of response, progression-free survival, and biomarker levels, with some assessments continuing up to 24 months. Safety and tolerability will be closely observed throughout the study period.
CONDITIONS
Brief Title
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed hepatocellular carcinoma not suitable for curative surgery or local therapy
- Documented disease progression after local therapy or treatment with sorafenib or lenvatinib, or intolerance/refusal of these agents
- At least one prior systemic therapy for hepatocellular carcinoma
- Eligible for treatment with nivolumab
- Measurable disease based on RECIST v1.1
- Child-Pugh class A liver function within 7 days before first study dose
- No history of hepatic encephalopathy
- No clinically significant ascites requiring active paracentesis; ascites on imaging only allowed
- If infected with HBV, antiviral therapy for at least 12 weeks and viral load below 100 IU/mL within 7 days before first dose
- No active co-infection with HBV and HCV or HBV and HDV
- No active drug or alcohol abuse
You will not qualify if you...
- Tyrosine kinase inhibitor treatment within 2 weeks before first study dose
- Esophageal or gastric variceal bleeding within 6 months
- Portal vein invasion at the main portal vein, inferior vena cava, or heart involvement by hepatocellular carcinoma
- Previous solid organ or blood cell transplantation
- Active autoimmune disease requiring systemic treatment within past 2 years
- Diagnosis of immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before first dose
- Locoregional therapy or major liver surgery within 6 weeks before first dose
- Minor surgery to liver or other site within 1 week before first dose
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 12 months
Participants receive nivolumab as a 30-minute IV infusion on Days 1 and 15 of each 28-day cycle. ABX196 is given as an IM injection 120 minutes after the nivolumab infusion on Day 1 of every other 28-day cycle (every 8 weeks).
Infusions and injections on Days 1 and 15 of each 28-day cycle; ABX196 administered every 8 weeks
Trial Site Locations
Total: 2 locations
1
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paul GINESTE, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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