Carcinoma, HepatocellularPhase 1/2NCT03897543

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

A Phase 1/2 study testing ABX196 in people with Carcinoma, Hepatocellular, run by Abivax S.A. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Hepatocellular
What is being tested?: ABX196
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: 18 Feb 2020to 14 Apr 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 who are intolerant to or who progressed on at least one line of Tyrosine Kinase Inhibitor (TKI) and/or Checkpoint inhibitor (CPI) therapy
Patients eligible to be treated with nivolumab or under treatment with nivolumab
Patients with measurable disease based on RECIST v1.1

Show all 13Show fewer

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
Patients with adequate organ function at screening

Who cannot join

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

Show all 9Show fewer

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
Patients treated with an investigational drug 2 weeks before first study dose

Trial locations and contacts

2 sites in 1 country.

United States2 sites

MD Anderson Cancer Center
Houston, Texas, 77030
Scripps Clinic Torrey Pines
La Jolla, California, 92037

Other trials in United States

About this study

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

Read the detailed description

The goal of this clinical trial is to investigate if ABX196 in combination with nivolumab can benefit adult patients with hepatocellular carcinoma.

Conditions: Carcinoma, Hepatocellular
Being tested: ABX196
Keywords: HCC, Nivolumab, ABX196
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABX196Drug
Also called Obefazimod
ABX196 is a synthetic agonist of invariant Natural Killer T (iNKT) cells

Study groups in NCT03897543
Study group	Role	What they receive
Dose Escalation for ABX196	Experimental	Dose escalation: ABX196 at 0.1, 0.2, or 0.4 µg i.m. was administered after completion of nivolumab infusion on Day 1 of every other 28-day treatment cycle (i.e., every 8 weeks). Nivolumab 240 mg i.v. was administered on Days 1 and 15 of each 28-day cycle. Receives: Drug: ABX196

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Severity of Adverse Events (AEs)
Incidence and severity of adverse events evaluated according to CTC-AE
Measured: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days)

Secondary outcomes (4)

Objective Response Rate (ORR)
Defined as the proportion of subjects with a best response of complete response or partial response according to RECIST V1.1
Measured: From first dose of treatment (randomization visit) up to 64 weeks treatment
Progression Free Survival (PFS)
Defined as time from first dose of ABX196 to disease progression or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
Time to Progression (TTP)
Defined as time from first dose of study ABXX196 to disease progression or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
Change in Alpha Fetoprotein Serum
Change in alpha fetoprotein serum concentrations
Measured: From first dose of treatment (randomization visit) up to 64 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202014 Apr 2022

First posted1 Apr 2019
Study start18 Feb 2020
Primary completion14 Apr 2022
Study completion14 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03897543
Sponsor's protocol ID: ABX196-001
Status last verified: Aug 2026
First submitted: 27 Mar 2019
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Hepatocellular trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT03897543
Acronym / sponsor ID: ABX196-001
Conditions: Carcinoma, Hepatocellular
Keywords: HCC, Nivolumab, ABX196
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Abivax S.A.Industry (pharma, biotech, devices)
Study start: 18 Feb 2020 (actual)
Primary completion: 14 Apr 2022 (actual)
Study completion: 14 Apr 2022 (actual)
First posted: 1 Apr 2019 (actual)
Results: Posted 29 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The goal of this clinical trial is to investigate if ABX196 in combination with nivolumab can benefit adult patients with hepatocellular carcinoma.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dose Escalation for ABX196	Experimental	Drug: ABX196Dose escalation: ABX196 at 0.1, 0.2, or 0.4 µg i.m. was administered after completion of nivolumab infusion on Day 1 of every other 28-day treatment cycle (i.e., every 8 weeks). Nivolumab 240 mg i.v. was administered on Days 1 and 15 of each 28-day cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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 who are intolerant to or who progressed on at least one line of Tyrosine Kinase Inhibitor (TKI) and/or Checkpoint inhibitor (CPI) therapy
Patients eligible to be treated with nivolumab or under treatment with nivolumab

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABX196Also: ObefazimodABX196 is a synthetic agonist of invariant Natural Killer T (iNKT) cells	Drug	Dose Escalation for ABX196

Primary outcome

Incidence and Severity of Adverse Events (AEs)
Time frame: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days)
Incidence and severity of adverse events evaluated according to CTC-AE

4 secondary outcomes

Objective Response Rate (ORR)
Time frame: From first dose of treatment (randomization visit) up to 64 weeks treatment
Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
Time to Progression (TTP)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
Change in Alpha Fetoprotein Serum
Time frame: From first dose of treatment (randomization visit) up to 64 weeks treatment

Results and safety

Results posted to the registry on 29 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABX196 0.1 µg i.m.	4	2
ABX196 0.2 µg i.m.	3	1
ABX196 0.4 µg i.m.	3	2

Primary outcome: Incidence and Severity of Adverse Events (AEs)

Time frame: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days). Count of participants. Unit: Participants

Measure	ABX196 0.1 µg i.m. n = 4	ABX196 0.2 µg i.m. n = 2	ABX196 0.4 µg i.m. n = 3
Any TEAE, n (%)	4	2	3
Any Serious TEAE, n (%)	1	0	0
Any ABX196-related TEAE, n (%)	2	2	0
Any nivolumab-related TEAE, n (%)	3	2	0
Any serious ABX196-related TEAE, n (%)	0	0	0
Any serious nivolumab-related TEAE, n (%)	0	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABX196 0.1 µg	1 of 4 (25%)	4 of 4 (100%)	0 of 4
ABX196 0.2 µg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
ABX196 0.4 µg	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Limitations and caveats (from the sponsor): A standard 3+3 design was used for the Dose Escalation Phase of the study: 18 patients were to be accrued. 10 patients enrolled in the Dose Escalation Phase of the study: Cohort 1 - ABX196 0.1 μg: 4 Cohort 2 - ABX196 0.1 μg: 3 Cohort 3 - ABX196 0.1 μg: 3 Patients were heavily pretreated for HCC. The Expansion Phase of the study was not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Carcinoma, Hepatocellular

RecruitingObservational study
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The Vanguard Study: Testing a New Way to Screen for Cancer
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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Darren SIGAL, MD principal investigator

Scripps Clinic/Scripps MD Anderson Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABX196 in people with Carcinoma, Hepatocellular, run by Abivax S.A. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (AEs) (time frame: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03897543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.