Carcinoma, Hepatocellular
Conditions
Keywords
HCC, Nivolumab, ABX196
Brief 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
Detailed description
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).
Interventions
DRUGABX196
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).
Sponsors
C3 Research Associates
Abivax S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Through study completion, an average of 1 year | Adverse Events evaluated according to CTC-AE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From date of randomization until the date of first documented progression, assessed up to 12 months | Partial and Complete response according to RECIST V1.1 |
| Duration of Response (DOR) | From date of randomization until the date of first documented progression, assessed up to 12 months | — |
| Progression-Free Survival | From date of randomization until the date of first documented progression, assessed up to 24 months | — |
| Alpha Fetoprotein Serum concentrations | Every 2 weeks, assessed up to 12 months | — |
Countries
United States
Contacts
Primary ContactPaul GINESTE, PhD
Outcome results
None listed