ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

NCT03897543 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ABX196-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Keywords

HCC; Nivolumab; ABX196

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  Adverse Events evaluated according to CTC-AE

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  From date of randomization until the date of first documented progression, assessed up to 12 months

• Duration of Response (DOR)

  From date of randomization until the date of first documented progression, assessed up to 12 months

• Progression-Free Survival

  From date of randomization until the date of first documented progression, assessed up to 24 months

• Alpha Fetoprotein Serum concentrations

  Every 2 weeks, assessed up to 12 months

Study Arms (1)

ABX196

EXPERIMENTAL

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

Drug: ABX196

Interventions

ABX196 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).

ABX196

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abivax S.A.: lead
• C3 Research Associates: collaborator

Study Sites (2)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

ABX196

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Darren SIGAL, MD

  Scripps Clinic/Scripps MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul GINESTE, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: August 30, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2023
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)