ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

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

Inclusion Criteria:

* 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
* Patients with at least one prior systemic therapy for HCC
* Patients eligible to be treated with nivolumab
* Patients with measurable disease based on RECIST v1.1
* 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

Exclusion Criteria:

* 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
* 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

Conditions4

Locations2 sites

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