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ABX196

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ABX196 · 1 trial · 1 indication

Phase 1 1
NCT03897543ABX196 in Combination With Nivolumab in Patients With Hepatocellular CarcinomaCarcinoma, Hepatocellular
RECRUITING48 Analytics
PHASE1RECRUITING
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
Carcinoma, Hepatocellular
NCT0389754348
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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 to 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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Frequently asked questions about ABX196

What is ABX196 used for in hepatocellular carcinoma?

ABX196 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 1 clinical development and is being evaluated in combination with nivolumab in patients with this condition.

What does ABX196 target?

The specific molecular target of ABX196 has not been disclosed. It is a small molecule modality being developed by Abivax SA for the treatment of hepatocellular carcinoma, and its mechanism of action is not publicly specified.

Who makes ABX196?

ABX196 is being developed by Abivax SA, a biopharmaceutical company. The company is conducting a Phase 1 clinical trial of ABX196 in combination with nivolumab for hepatocellular carcinoma.

What phase is ABX196 in?

ABX196 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with hepatocellular carcinoma.

What clinical trials is ABX196 in?

ABX196 is being studied in one active Phase 1 clinical trial, NCT03897543, titled 'ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma'. This trial is recruiting 48 participants in the United States.

Is ABX196 the same as nivolumab?

No, ABX196 is not the same as nivolumab. ABX196 is an investigational small molecule developed by Abivax SA, while nivolumab is a separate, approved immunotherapy drug. In the clinical trial NCT03897543, ABX196 is being tested in combination with nivolumab.