Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABX196 · 1 trial · 1 indication
Incidence and severity of adverse events evaluated according to CTC-AE
| Arm | Type | Description |
|---|---|---|
| Dose Escalation for ABX196 | EXPERIMENTAL | Dose escalation: ABX196 at 0.1, 0.2, or 0.4 µg i.m. was administered after completion of nivolumab infusion on Day 1 of every other 28-day treatment cycle (i.e., every 8 weeks). Nivolumab 240 mg i.v. was administered on Days 1 and 15 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| ABX196 | DRUG | ABX196 is a synthetic agonist of invariant Natural Killer T (iNKT) cells |
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 who are intolerant to or who progressed on at least one line of Tyrosine Kinase Inh...
ABX196 is an investigational small molecule being studied for hepatocellular carcinoma, a form of liver cancer. It has been evaluated in a Phase 1 clinical trial in adults with this condition. It is not an approved therapy and remains in clinical development.
ABX196 targets invariant natural killer T cells, or iNKT cells. It is a small molecule designed to act on this immune cell population. This mechanism is being explored in the context of hepatocellular carcinoma.
ABX196 is being developed by Abivax SA, which trades under the ticker ABVX. The company is the sponsor of the clinical program for this asset.
ABX196 is in Phase 1 clinical development. The program has completed one Phase 1 trial. It is an investigational agent and has not been approved for any indication.
ABX196 has been studied in a Phase 1 trial, NCT03897543, titled ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma. The trial was conducted in the United States, enrolled 10 patients, and is now completed.
No, ABX196 is not approved. It is an investigational small molecule in Phase 1 clinical development for hepatocellular carcinoma. The only recorded trial, NCT03897543, has completed, and the drug remains unapproved.