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ABC294640

A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma

Ensayo de RedHill Biopharma Ltd. en Cholangiocarcinoma · Cholangiocarcinoma Non-resectable · Cholangiocarcinoma, Perihilar · Cholangiocarcinoma, Extrahepatic · Cholangiocarcinoma, Intrahepatic (del registro, en inglés).

Más ensayos de: Colangiocarcinoma.

Fase

Fase 2

Estado

Completado

Participantes

65

previstos

Centros

5

Fin del objetivo primario

jun 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2018.

Qué mide

Part1 - Determine Response Rate (At least 4 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician.

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Ficha completa en ClinicalTrials.gov (NCT03377179), actualizada en jul 2025.