Trial | NCT03897543  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ABX196

  • Study Participants

    48
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
This is an 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. The study consists of 2 phases, a Dose Escalation Phase and an Expansion Phase. Nivolumab will be administered, consistent with the US prescribing information, as a 30-minute IV infusion on Days 1 and 15 of each 28-Day cycle. 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 cycle (i.e., every 8 weeks).
Study Started
Aug 30
2019
Primary Completion
Jun 30
2021
Anticipated
Study Completion
Jun 30
2023
Anticipated
Last Update
Mar 26
2021

Drug ABX196

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).

ABX196 Experimental

IM injection of 0.1, 0.2, and 0.4 µg of ABX196

Criteria 

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
No Results Posted