ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

March 25, 2021 updated by: Abivax S.A.

A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Clinic Torrey Pines
        • Contact:
          • Darren Sigal, Prof.
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABX196
IM injection of 0.1, 0.2, and 0.4 µg of ABX196
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: Through study completion, an average of 1 year
Adverse Events evaluated according to CTC-AE
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From date of randomization until the date of first documented progression, assessed up to 12 months
Partial and Complete response according to RECIST V1.1
From date of randomization until the date of first documented progression, assessed up to 12 months
Duration of Response (DOR)
Time Frame: From date of randomization until the date of first documented progression, assessed up to 12 months
From date of randomization until the date of first documented progression, assessed up to 12 months
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented progression, assessed up to 24 months
From date of randomization until the date of first documented progression, assessed up to 24 months
Alpha Fetoprotein Serum concentrations
Time Frame: Every 2 weeks, assessed up to 12 months
Every 2 weeks, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abivax S.A.

Collaborators

C3 Research Associates

Investigators

  • Principal Investigator: Darren SIGAL, MD, Scripps Clinic/Scripps MD Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2019

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABX196-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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