ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

NCT ID: NCT03897543

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2023-06-30

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

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).

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABX196

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

Group Type: EXPERIMENTAL

ABX196

Intervention Type: DRUG

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).

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C3 Research Associates

UNKNOWN

Sponsor Role: collaborator

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darren SIGAL, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic/Scripps MD Anderson Cancer Center

Locations

Scripps Clinic Torrey Pines

La Jolla, California, United States

Site Status: RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul GINESTE, PhD

Role: CONTACT

paul.gineste@abivax.com

+33 153 830 961

Facility Contacts

Darren Sigal, Prof.

Role: primary

Ahmed Kaseb, MD

Role: primary

akaseb@mdanderson.org

713-792-2828

Other Identifiers

ABX196-001

Identifier Type: -

Identifier Source: org_study_id