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ABX196

Phase 1

Carcinoma, Hepatocellular | Small molecule | Oncology |Abivax SA|Last Updated: Mar 26, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03897543ABX196 in Combination With Nivolumab in Patients With Hepatocellular CarcinomaPHASE1 RECRUITING 48 — — Aug 30, 2019Jun 30, 2023Mar 26, 20212 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Through study completion, an average of 1 year

Adverse Events evaluated according to CTC-AE

Secondary Endpoints
Objective Response Rate (ORR)
From date of randomization until the date of first documented progression, assessed up to 12 months
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABX196EXPERIMENTALIM injection of 0.1, 0.2, and 0.4 µg of ABX196
Interventions
NameTypeDescription
ABX196DRUGABX196 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).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03897543primaryCompletionDate: changed
LOWMay 24, 2026NCT03897543studyFirstPostDate: changed