ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Part of paid clinical trials in La Jolla, California.

Sponsor
Abivax S.A.
Study ID
NCT03897543
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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

Key Dates

Start date
Aug 30, 2019
Status verified
Mar 2021
Primary completion
Jun 30, 2021
Completion
Jun 30, 2023

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABX196
    IM injection of 0.1, 0.2, and 0.4 µg of ABX196

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Scripps Clinic Torrey PinesLa JollaCalifornia92037
Darren Sigal, Prof.
MD Anderson Cancer CenterHoustonTexas77030
Ahmed Kaseb, MD
[email protected]
713-792-2828

Find similar trials in La Jolla, CA

By research site
Scripps Clinic Torrey Pines· La Jolla, CAMD Anderson Cancer Center· Houston, TX

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