Phase 3 Study of CGT9486+ Sunitinib vs. Sunitinib in Subjects with Gastrointestinal stromal tumours
Research type
Research Study
Full title
A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
IRAS ID
1005416
Contact name
Kevin Moynihan
Contact email
Sponsor organisation
Cogent Biosciences, Inc.
Eudract number
2022-000682-40
Clinicaltrials.gov Identifier
Research summary
Gastrointestinal Stromal Tumours (GIST) is a cancer that arises due to gain of function mutations (change in one strand of DNA) in the receptor tyrosine kinase KIT or PDGFR alpha. Imatinib is considered first-line therapy for patients with GIST, meaning doctors typically prescribe imatinib first to treat patients. However, imatinib is restricted in the range of mutations that they can target. Sunitinib is the second-line therapy used to treat GIST but half of these resistant tumours contain A-loop mutations which do not have a current therapy.
Cogent BioSciences are sponsoring to test the effectiveness and safety of the CGT9486 which has shown potential in working against these more resistant A-loop mutations. Researchers will compare how CGT9486 plus sunitinib affects GIST compared to just treatment with sunitinib alone. This global Phase 3 study has three parts: Part 1a, Part 1b, and Part 2. A total of 426 patients will participate in this study and approximately 388 patients will participate in this part 2 of the study. The UK is participating only in Part 2. To be eligible for this study participants must have confirmed locally advanced, metastatic and/ or unresectable GIST and have documented disease progression on or intolerance to imatinib.
Participants will be randomly assigned and will have an equal chance to be assigned to either cohort (like flipping a coin). Patients in both cohorts will receive treatment during 28-day treatment cycles and CGT9486/ sunitinib will be taken orally without food. The total number of treatment cycles will depend on how participants respond to study treatment but the maximum length of time will be 34 months. There is a cross over element to this study that if participants are randomised to be in the control group (receiving sunitinib only) and GIST progresses, or gets worse, the study doctor may decide to switch their treatment assignment to receive CGT9486 plus sunitinib.REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0001
Date of REC Opinion
4 Jul 2023
REC opinion
Further Information Favourable Opinion