TransThera Completes First Patient Dosing in US for Global Phase 3 Trial of Tinengotinib in FGFRi Relapsed/Refractory Cholangiocarcinoma

22 December 2023 | Friday | News


TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announces the first patient has been dosed in the US for the Phase 3 trial FIRST-308 of tinengotinib (TT-00420), an investigational next generation FGFR inhibitor to treat advanced FGFR-altered cholangiocarcinoma(CCA)patients who had progressed on prior systemic therapy and FGFR inhibitors.
Image Source : Public Domain

Image Source : Public Domain

This study is a Phase 3, randomized, controlled, global multicenter study to evaluate the efficacy and safety of oral tinengotinib versus physician's choice in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma. The study is planned to be conducted in the US, the EU, the UK, Asia, and other countries and regions, and the final results will support a global marketing application for tinengotinib.

"We are thrilled to have dosed the first US patient in our Phase 3 trial and appreciate the effort and participation by clinicians and patient. It is also an important indicator of TransThera's international clinical execution capabilities."  said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. "We will be committed to advancing the development of tinengotinib that has potential to demonstrate clinical benefit for CCA patients with high unmet medical needs and are looking forward to the progress in FIRST-308 study to bring the novel therapy to CCA patients."

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