Clinical Trials /

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

NCT03897543

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

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
ABX196ABX196

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

NameTypeDescriptionInterventions
ABX196ExperimentalIM injection of 0.1, 0.2, and 0.4 µg of ABX196
  • 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

  • HCC
  • Nivolumab
  • ABX196

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