ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Sponsor: Abivax S.A.
ClinicalTrials ID:NCT03897543
This phase 1-2 study assesses ABX196 with nivolumab in hepatocellular carcinoma patients. It includes dose escalation and expansion phases. Eligibility requires adults with ECOG 0-1, prior systemic therapy, and Child-Pugh class A. ABX196 is given IM every 8 weeks post-nivolumab infusion. Participants must have no significant ascites or active substance abuse.
Patient Parameters
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Program Overview
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
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).
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Scripps Clinic Torrey Pines | 92037 | La Jolla | California |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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