Recruiting
Phase 1
Phase 2

ABX196 & Nivolumab

Sponsor:

Abivax S.A.

Code:

NCT03897543

Conditions

Carcinoma, Hepatocellular

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABX196

Study Details

Brief summary:

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

Conditions

Carcinoma, Hepatocellular

Study ID

NCT03897543

Start date

Aug 30, 2019

Status verified date

Mar, 2021

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jun 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABX196

IM injection of 0.1, 0.2, and 0.4 µg of ABX196

Interventions

ABX196

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 treatment cycle (i.e., every 8 weeks).

Primary outcome measure

  • Incidence of adverse events (AEs) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Paul GINESTE, PhD

+33 153 830 961paul.gineste@abivax.com

Locations

Scripps Clinic Torrey Pines

Recruiting

La Jolla, California, United States, 92037

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ahmed Kaseb, MD

713-792-2828akaseb@mdanderson.org

More Information

Sponsor

Abivax S.A.

Last update posted

Mar 26, 2021

Last verified

Mar, 2021

Keywords

  • HCC
  • Nivolumab
  • ABX196

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abivax S.A. on 2021-03-26.