Health TrialsbyHealthPanel

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

ConditionCarcinoma, Hepatocellular
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbivax S.A.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: ABX196Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Adverse Events evaluated according to CTC-AE

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Objective Response Rate (ORR)

Partial and Complete response according to RECIST V1.1

Time frame
From date of randomization until the date of first documented progression, assessed up to 12 months
2

Duration of Response (DOR)

Time frame
From date of randomization until the date of first documented progression, assessed up to 12 months
3

Progression-Free Survival

Time frame
From date of randomization until the date of first documented progression, assessed up to 24 months
4

Alpha Fetoprotein Serum concentrations

Time frame
Every 2 weeks, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abivax S.A.

Lead sponsor

C3 Research Associates

Collaborator

Source ClinicalTrials.gov
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