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
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
Treatments tested in this trial
- ABX196
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Abivax S.A.
Lead sponsor
C3 Research Associates
Collaborator
Source ClinicalTrials.gov