Description:
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
Title
- Brief Title: ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
- Official Title: A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
ABX196-001
- NCT ID:
NCT03897543
Conditions
- Carcinoma, Hepatocellular
Interventions
Drug | Synonyms | Arms |
---|
ABX196 | | ABX196 |
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
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).
Trial Arms
Name | Type | Description | Interventions |
---|
ABX196 | Experimental | IM injection of 0.1, 0.2, and 0.4 µg of ABX196 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Adverse Events evaluated according to CTC-AE |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | From date of randomization until the date of first documented progression, assessed up to 12 months |
Safety Issue: | |
Description: | Partial and Complete response according to RECIST V1.1 |
Measure: | Duration of Response (DOR) |
Time Frame: | From date of randomization until the date of first documented progression, assessed up to 12 months |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival |
Time Frame: | From date of randomization until the date of first documented progression, assessed up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Alpha Fetoprotein Serum concentrations |
Time Frame: | Every 2 weeks, assessed up to 12 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Abivax S.A. |
Trial Keywords
Last Updated
March 26, 2021