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Clinical Trials > Targeted Therapy

It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice.  We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.

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A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)

Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…

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A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

This is a global Phase 2 study for 2nd line treatment of patients with advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other FGFR genetic alteration. Patients must have been previously treated with gemcitabine chemotherapy or combination chemotherapy with gemcitabine.

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PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).

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Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

Study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Cycles will continue until disease progression or unacceptable toxicity.

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FUZE Clinical Trial

The FUZE Clinical Trial is evaluating an oral investigational medication, called Debio 1347, that may block cancer cell growth. Debio 1347 targets tumors with a specific genetic alteration, called a fusion, of FGFR 1, 2 or 3 (fibroblast growth factor receptor).

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A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given with Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) alone in Patients with Intrahepatic Cholangiocarcinoma

Patients with intrahepatic cholangiocarcinoma who enroll in this study will receive either Melphalan with the investigational Hepatic Delivery System (called Melphalan/HDS) or Cisplatin and Gemcitabine alone, which is standard of care. Patients who enroll will receive gem/cis followed by melphalan, compared to gem/cis.

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A Study of TAS-120 in Patients With Advanced Solid Tumors

This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities.

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Phase I study of ZW25 (bispecific antibody) in patients with advanced HER2-expressing cancers

ZWI-ZW25-101 is a clinical study of ZW25 as a treatment for advanced (unresectable) and/or metastatic HER2-expressing cancers, including cholangiocarcinoma. Patients will receive once a week or once every other two weeks by IV infusion and will be monitored for safety and to determine response to the drug.

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Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

Study Name Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations ClinicalTrials.gov Identifier (if applicable) NCT01948297 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name The University of Texas MD Anderson Cancer Center Institution Address 1515 Holcombe Blvd City Houston…

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A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors With FGF/FGFR-Related Abnormalities

FGFR gene abnormalities have been linked to various cancers. TAS-120 is an inhibitor of FGFR and therefore is being studied as a therapy for cancer. TAS-120 is a pill that you will take every day. You will see a doctor every 21 days, but you may have blood tests performed more often. You will have your cancer re-staged every 6-9 weeks.

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