Five for Friday – 5 clinical trials presented at GI ASCO

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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.

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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.

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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.

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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.

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If you have something you’d like to share, please reach out to Allison Deragon at allison.deragon@cholangiocarcinoma.org.

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