TransThera Announces the Global Multicenter Phase 3 Clinical Trial Completed First Patient Dosing in the US Evaluating Tinengotinib in FGFRi Relapsed/Refractory Patients with Cholangiocarcinoma
21 Dec 2023
Fast TrackPhase 3Orphan Drug
NANJING, China and GAITHURSBURG, Md., Dec. 21, 2023 /PRNewswire/ -- 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.
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 InhibitorInhibitor-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."
About tinengotinib
Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan-Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China.
About TransThera
TransThera, including TransThera Sciences (Nanjing), Inc. and TransThera Sciences (US) Inc., is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via the internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, inflammatory, and cardiovascular diseases.
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