Targeted Therapy

Study Name FIDES-01: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions or FGFR2 gene mutations or amplifications ClinicalTrials.gov Identifier (if applicable) NCT03230318 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name Please go to ClinicalTrials.gov to view…

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.

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.

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.

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.

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…

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.

This Phase II clinical trial will establish the effectiveness of BGJ398 in patients harboring the FGFR2 gene fusion/translocation, which are errors in the DNA. Adult patients with histologically or cytologically confirmed (tumor biopsy), advanced or metastatic cholangiocarcinoma harboring the FGFR2 gene fusion/ translocation are eligible for enrollment. Phase II clinical trials give doctors more information about the safety of the drug and how well it works.

Approximately 55 adult patients over age 18, both male and female will be enrolled. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule

This is an open-label (both the patient and the investigator know what the patient is receiving), Phase 2 study in patient with cholangiocarcinoma who have failed at least one prior line of therapy.

An Open-label, Non-Randomized (the participants are not assigned by chance to different treatment groups), Multi-center, Phase I Study. Phase II Dose of the Orally taken Mutant IDH Inhibitor BAY 1436032. Cohorts will consist of patients representing the following IDH1-R132X-mutant intrahepatic cholangioncarcinoma, glioblastoma/ anaplastic glioma

This open-label study is looking at targeted therapies in patients with advanced cancer for whom there is no available, beneficial treatment.