FIRST-308
Research type
Research Study
Full title
A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician’s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
IRAS ID
1008585
Contact name
Angie Sun
Contact email
Sponsor organisation
TransThera Sciences (Nanjing), Inc.
Clinicaltrials.gov Identifier
Research summary
Fibroblast growth factor receptor (FGFR)-altered, chemotherapy- and FGFR inhibitor-refractory/relapsed cholangiocarcinoma (R/R CCA) is a type of a cancer that forms in the small tubes that carry bile and are characterized by an aggressive disease course and poor clinical outcome. R/R CCA who have failed chemotherapy and prior FGFR inhibitors has not been controlled with the available standard therapies, meaning that the cancer cells are growing despite prior treatments (refractory) or, the cancer has come back after a temporary recovery (relapsed).
TransThera Sciences (Nanjing), Inc. (TransThera) has begun a study of an investigational medicine called tinengotinib as a possible treatment for R/R CCA. Tinengotinib is thought to work by preventing processes that contribute to further cell growth in tumours and also helps limit blood and nutrient supply to tumours in order slow tumour growth.
The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with other approved choice of chemotherapy treatment for R/R CCA cancers. The purpose of Part A of the study will be to determine the optimal dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the other approved and available choice of treatments for this cancer.
TransThera is sponsoring this study and it will take place at approximately 100 centres in 14 countries.
This study will be divided into 2 parts: Part A and Part B. Approximately 50 participants are expected to be recruited in Part A and an additional 150 participants are expected to be recruited in Part B.REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0354
Date of REC Opinion
8 Dec 2023
REC opinion
Further Information Unfavourable Opinion