Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABC294640 · 1 trial · 5 indications
To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640.
To determine the Durable Disease Control Rate (DDCR) of CCA defined as Disease Control Rate (DCR) of at least 4 months duration to treatment with ABC294640 and HCQ
| Arm | Type | Description |
|---|---|---|
| ABC294640 +/- HCQ treatment | EXPERIMENTAL | Part 1: All participants will be receiving ABC294640, 500 mg twice a day (BID), continuously in 28 day cycles Part 2: All participants will be receiving ABC294640, 500 mg twice a day (BID) and HCQ at a determined level, continuously in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| ABC294640 | DRUG | Two 250 mg capsules of ABC294640 will be taken twice daily |
| Hydroxychloroquine Sulfate 200 MG | DRUG | HCQ tablets will be taken at a dose that will be determined |
Inclusion Criteria: 1. Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA. 2. Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA. 3. The tumor is unresectable and not amenable to curative therapy. 4. One or more tumors measur...
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ABC294640 is an investigational small molecule being studied for the treatment of advanced cholangiocarcinoma, including non-resectable, perihilar, extrahepatic, and intrahepatic forms of the disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ABC294640 is a small molecule that targets sphingosine kinase 2, an enzyme involved in the production of sphingosine-1-phosphate, which plays a role in cell growth and survival. By inhibiting this enzyme, ABC294640 aims to reduce tumor growth in cholangiocarcinoma.
ABC294640 is being developed by Redhill Biopharma Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced cholangiocarcinoma.
ABC294640 is in Phase 2 clinical development for the treatment of advanced cholangiocarcinoma. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies for commercial use.
ABC294640 has been studied in a Phase 2 clinical trial with the identifier NCT03377179, titled 'A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma.' The trial enrolled 65 participants in the United States and has been completed.
ABC294640 is also known as opaganib. It is the same drug, and the name opaganib is used interchangeably in some contexts. The drug is being developed by Redhill Biopharma for the treatment of cholangiocarcinoma.