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

Who is this study for? Patients with Hepatocellular Carcinoma
What treatments are being studied? ABX197
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Scripps Clinic Torrey Pines
RECRUITING
La Jolla
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Paul GINESTE, PhD
paul.gineste@abivax.com
+33 153 830 961
Time Frame
Start Date: 2019-08-30
Estimated Completion Date: 2023-06-30
Participants
Target number of participants: 48
Treatments
Experimental: ABX196
IM injection of 0.1, 0.2, and 0.4 µg of ABX196
Related Therapeutic Areas
Sponsors
Leads: Abivax S.A.
Collaborators: C3 Research Associates

This content was sourced from clinicaltrials.gov

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