A Phase 3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients with Previously Treated Advanced Biliary Tract Cancer
Nanvuranlat is being evaluated as a safe and effective treatment for patients with previously treated advanced biliary tract cancer.
The study enrolls patients with previously treated advanced biliary tract cancer to determine the optimal dose of the investigational agent nanvuranlat and compare its safety and efficacy with standard chemotherapy regimens. Participants are randomized in two parts: Part A allocates patients to one of four dose levels or standard treatment; Part B directly compares nanvuranlat with standard care. Treatment is given every two weeks, with ongoing safety monitoring and tumor response assessment using RECIST v1.1. Pharmacokinetic and biomarker analyses evaluate nanvuranlat’s mechanism of action and potential genetic predictors of response.
Biliary tract cancer has a poor prognosis and limited therapeutic options. Demonstrating that nanvuranlat is safe and effective could provide a new therapeutic avenue for patients who have exhausted standard treatments.
Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.
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