Skip to content

Clinical Trials > Beyond First Line 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.

Now Enrolling

Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.

Read More

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.

Read More

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.

Read More

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).

Read More

Tree Topp

The study drug, varlitinib, is an investigational anti-tumor product, delivered in the form of tablets. The study drug has been administered as a single and combination treatment to patients with metastatic gastric cancer, gastro-esophageal tumors, breast cancer, and biliary tract cancer (BTC). Laboratory studies and animal research suggest that the study drug stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that the study drug may be effective in targeting and inhibiting (preventing) the pathways of certain proteins in cells called “HER” (human epidermal growth factor receptor). The “HER” protein is important in types of cancer such as cholangiocarcinoma (BTC), gastric cancer, breast cancer, and others. Varlitinib has shown activity in BTC. In this study, patients will receive study drug plus capecitabine, or placebo plus capecitabine. Inclusion allows all forms of BTC and there is no biomarker-based patient selection.

Read More

GNS561-CL-I-Q-0211: Phase 1/2 Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients with Primary Liver Cancer which includes Intrahepatic cholangiocarcinoma patients

This is a multicenter, open-label, uncontrolled, repeat-dose phase 1/2a study designed to evaluate the safety profile and to determine the Recommended Dose of GNS561 in patients with advanced advanced primary liver cancer (Hepatocarcinoma, Intrahepatic Cholangiocarcinoma). This study consists of 2 parts: escalation and expansion phase.

Read More

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.

Read More

A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

This is a phase II study of the combination of 2 immunotherapy drugs (durvalumab and tremelimumab) with radiation therapy in patients with hepatocellular carcinoma (HCC) with an exploratory cohort of patients with metastatic biliary tract cancer (BTC).

Read More

A Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further evaluate its safety, tolerability, and efficacy in expansion cohorts once the MTD is determined.

Read More

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.

Read More
WordPress Image Lightbox Plugin
Back to Top