RecruitingPhase 1Phase 2NCT03897543

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

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


Sponsor

Abivax S.A.

Enrollment

48 participants

Start Date

Aug 30, 2019

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment for advanced liver cancer (hepatocellular carcinoma, or HCC): an experimental drug called ABX196, which activates a special group of immune cells (natural killer T cells), combined with nivolumab (a standard immunotherapy drug). The goal is to see if this combination safely enhances the immune system's ability to attack liver tumors. **You may be eligible if...** - You are 18 or older with HCC that cannot be cured by surgery or local treatment - Your cancer has grown or spread despite prior treatment with sorafenib or lenvatinib, or you could not tolerate these drugs - You have received at least one prior systemic treatment for HCC - You have measurable disease on imaging - Your liver function is well preserved (Child-Pugh class A) - You have no history of confusion caused by liver failure or significant abdominal fluid buildup **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have serious infections including HIV, hepatitis B, or active hepatitis C - You are pregnant or breastfeeding - Your liver function or organ health does not meet required standards Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABX196

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).


Locations(2)

Scripps Clinic Torrey Pines

La Jolla, California, United States

MD Anderson Cancer Center

Houston, Texas, United States

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NCT03897543


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