FIRST-308

FIRST-308 is a clinical trial evaluating the targeted therapy tinengotinib in patients with advanced cholangiocarcinoma who have a FGFR2 mutation and have previously received chemotherapy and targeted therapy with a FGFR inhibitor.

This global Phase III study will compare the safety and efficacy of tinengotinib against the physician’s choice of FOLFOX or FOLFIRI.

The study is recruiting patients in the UK, US, EU, and Asia.

Key details

• Purpose: To evaluate the efficacy and safety of tinengotinib compared to FOLFOX/FOLFIRI.
• Location: Global (including UK, US, EU, and Asia)
• Phase: Phase III
• Treatment Arms: Participants will be randomly assigned to one of the following treatment arms in the ratio 2:2:1 – Tinengotinib 8mg, Tinengotinib 10mg, Physician’s Choice (FOLFOX or FOLFIRI)
• Eligibility: Patients must have advanced CCA with a FGFR2 mutation and must previously have received chemotherapy and targeted therapy with a FGFR inhibitor – please note that additional eligibility and exclusion criteria apply
• Enrolment: Approximately 200 subjects will be enrolled globally
• Recruitment: The study is recruiting participants
• UK Study Sites: London, Manchester, and Nottingham

How to get involved

• Discuss potential eligibility with your doctor or healthcare professional.
• You can also contact the study team directly through the Be Part of Research website.
• Full details of the trial can be found at: https://clinicaltrials.gov/study/NCT05948475

The UK trial sites are currently open and recruiting:

• University College London Hospital (UCLH) – Lead: Professor John Bridgewater
• The Christie, Manchester – Lead: Dr Mairéad McNamara
• Nottingham – Lead: Professor Arvind Arora
• Royal Marsden Hospital, London – Lead: Professor David Cunningham

The trial is open and recruiting in several European locations which you can find on the European Medicines Agency (EMA) clinical trials page: HERE