Clinical Trials > All Submitted Clinical Trials

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Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors

We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.

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HERIZON-BTC-01: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) in Patients with Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

This study will test the effectiveness & safety of zanidatamab (ZW25) as a treatment for biliary tract cancers (cholangiocarcinoma or gall bladder cancer) that contain extra copies of a gene called HER2. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer which has progressed following standard of care therapy.

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CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)

CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.

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CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.

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A Phase I, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of GQ1001, a HER2 Antibody-Drug Conjugate, in Patients with HER2-Positive Advanced Solid Tumors

This is a Phase I dose finding study of GQ1001, an anti-HER2 antibody drug conjugate in adults with HER2-positive solid tumors. GQ1001 is administered once every 21-days. Routine safety lab tests and other necessary medical monitoring will be conducted by the site medical staff during the study.

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Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

This phase II trial studies how well the drug pevonedistat—when given alone or in combination with chemotherapy (paclitaxel and carboplatin)—works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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NuTIde:121

NUC-1031, a new type of chemotherapy drug (called a ProTide) kills cancer cells by preventing DNA replication, similar to gemcitabine. There are several cancer resistance mechanisms known to limit the effectiveness of gemcitabine. NUC-1031 has been specifically designed to overcome these.
Patients will be randomised into NUC-1031 arm or SOC arm

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Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.

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A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma

This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.

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TAS-120-301(FOENIX-CCA3)

FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been
identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.

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