ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Purpose
Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma
Condition
- Carcinoma, Hepatocellular
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Men or women, Age ≥18 years - Patients with ECOG performance status 0 or 1 - Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy - Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent - Patients with at least one prior systemic therapy for HCC - Patients eligible to be treated with nivolumab - Patients with measurable disease based on RECIST v1.1 - Patients with Child-Pugh class A liver score within 7 days of first study dose - Patients with no history of hepatic encephalopathy - Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible) - Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be <100 IU/mL within 7 days of first study dose - Patients with no active co-infection with HBV and HCV or HBV and HDV - Patients with no active drug or alcohol abuse
Exclusion Criteria
- Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose - Patients with esophageal or gastric variceal bleeding within the past 6 months - Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging - Patients with previous solid organ or hematologic transplantation - Patients with active autoimmune disease requiring systemic treatment in the past 2 years - Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose - Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose - Patients with minor surgery to liver or another site within 1 week before first study dose
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABX196 |
IM injection of 0.1, 0.2, and 0.4 µg of ABX196 |
|
Recruiting Locations
La Jolla 5363943, California 5332921 92037
Darren Sigal, Prof.
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- Abivax S.A.
Detailed Description
This is an open-label, uncontrolled phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma. The study consists of 2 phases, a Dose Escalation Phase and an Expansion Phase. Nivolumab will be administered, consistent with the US prescribing information, as a 30-minute IV infusion on Days 1 and 15 of each 28-Day cycle. ABX196 will be administered as an IM injection 120 minutes (+/- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day cycle (i.e., every 8 weeks).