The American Society of Clinical Oncology Gastrointestinal Cancers Symposium (GI ASCO) recognizes the important role clinical trials play in cancer advancements, especially GI cancers.
We are pleased to share five clinical trials in progress that were presented this year at GI ASCO. These are ongoing trials that are currently recruiting cholangiocarcinoma patients. Please visit our clinical trials section where you can find more ongoing trials.
A phase I study of LY3410738, a first-in-class covalent inhibitor of mutant IDH1 in cholangiocarcinoma and other advanced solid tumors.
A multi-center, global phase I trial currently enrolling patients with mutant mIDH1 R132 advanced cholangiocarcinoma to be treated with a newly developed IDH1 inhibitor. Patients who received prior therapy, including another IDH1 inhibitor, are eligible for trial enrollment.
ClinicalTrials.gov Link: https://www.clinicaltrials.gov/ct2/show/NCT04521686
Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121).
NUC-1031 is a modified form of gemcitabine designed to overcome gemcitabine resistance mechanisms. The previous phase I trials showed that combined NUC-1031 and cisplatin has an encouraging efficacy and tolerable toxicity. Based on these results, a phase III NuTide:121 trial is currently open for patients’ enrollment. Only patients who had no prior therapy are eligible and will be randomized into NUC-1031 + cisplatin versus gemcitabine + cisplatin. NuTide:121 is currently being conducted at approximately 130 sites across North America, Europe, and Asia Pacific countries.
ClinicalTrials.gov Link: https://www.clinicaltrials.gov/ct2/show/NCT04163900
A phase IIb, open-label, single-arm study of Zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers.
Zanidatamab (ZW25), HER2 targeted therapy, received an FDA breakthrough designation in biliary tract cancer patients. An ongoing phase I trial (ZWI-ZW25-101; NCT02892123) showed that Zanidatamab has an encouraging efficacy and tolerable toxicity in biliary tract cancer patients. These results led to the initiation of a multi-center global phase II clinical trial to evaluate the efficacy and safety of Zanidatamab for HER2 amplification biliary tract cancer patients who received at least one prior systemic therapy.
ClinicalTrials.gov Link: https://www.clinicaltrials.gov/ct2/show/NCT04466891
Phase II trial of the PARP inhibitor, niraparib, in BRCA1-Associated Protein 1 (BAP1) and other DNA damage response (DDR) pathway deficient neoplasms including cholangiocarcinoma.
A multi-center, global phase II trial evaluates the efficacy and safety of oral niraparib, PARP inhibitor, in two groups. Group A includes BAP1 mutated cholangiocarcinoma patients, and group B includes cholangiocarcinoma patients who harbor other DNA repair genes. If you are interested in this trail, you can find the list of eligible mutations through this ASCO link https://meetinglibrary.asco.org/record/194322/abstract
ClinicalTrials.gov Link: https://www.clinicaltrials.gov/ct2/show/NCT03207347