TransThera will use the Phase III results to support a global marketing application for the candidate. Image credit: SewCreamStudio / Shutterstock

TransThera has dosed the first subject in the Phase III trial investigating tinengotinib in patients with bile duct cancer in the US.

The Phase III study (NCT05948475) will evaluate the efficacy and safety of oral tinengotinib (TT-00420) versus physician’s choice in subjects with FGFR-altered, chemotherapy- and FGFR inhibitor-refractory or relapsed cholangiocarcinoma (CCA). CCA is a type of cancer that forms in the bile ducts.

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The study will be conducted in the US, EU, UK, Asia, and other countries and regions. The results from the trial will support a global marketing application for tinengotinib.

Patients in the FIRST-308 study will be randomised in a 2:2:1 ratio. In the first experimental arm, patients will receive once daily tinengotinib at 8 mg orally in 28-day cycles. The second arm will receive once daily tinengotinib at 10mg orally in 28-day cycles. The final cohort will receive FOLFOX or FOLFIRI for every two weeks with two administrations per 28-day cycle.

FOLFIRI is a combination of fluorouracil, leucovorin and while FOLFOX is a combination of fluorouracil, leucovorin and oxaliplatin.

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Tinengotinib is an investigational next-generation FGFR inhibitor to treat advanced FGFR-altered CCA patients who had progressed on prior systemic therapy and FGFR inhibitors. Tinengotinib exerts antitumor effects by targeting tumour cells and improving the tumour microenvironment.

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It was granted the orphan drug designation and fast track designation by the US Food and Drug Administration (FDA) for the treatment of CCA.

In July 2023, tinengotinib was granted the breakthrough therapy designation by the National Medical Products Administration (NMPA) in China.

TransThera is also conducting two Phase I/II trials (NCT04742959 and NCT05253053) with the candidate as monotherapy and combination therapy in patients with advanced solid tumours, one in China and another in the US.

According to GlobalData Pharmaceutical Intelligence Center, TransThera has five ongoing trials, one planned trial and two completed trials of tinengotinib. The trials are across 14 different oncological indications which also include prostate, gastric and bladder cancers.

GlobalData is the parent company of the Clinical Trials Arena.