(VELA) Study of BLU-222 in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors
IRAS ID
1006150
Contact name
Tanya Green
Contact email
Sponsor organisation
Blueprint Medicines Corporation
Clinicaltrials.gov Identifier
Research summary
This first-in-human study will evaluate the recommended dose, safety, and effects of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable advanced solid tumours, including ovarian, endometrial, and hormone receptor positive (HR+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This study will enroll about 100-140 patients during Phase 1 and about 226 additional patients in Phase 2; globally in North America, Europe, and Asia Pacific.
This is an open-label study. This means that study doctor and the study staff, the sponsor, and other concerned parties will know the drug and the doses that participants are given. All patients participating in this research study will receive BLU-222.
There are 2 phases planned for the study. The first phase is called 'Phase 1', where different doses of BLU-222 will be given to patients to identify the recommended dose for the second phase of the study, known as 'Phase 2'. Phase 2 of the study will continue to test BLU-222 taken alone and in combination with other available therapies at a selected dose based on what is learned in the first phase. In the second phase, the study will continue to evaluate whether BLU-222 is safe and tolerable, as well as how patients cancer responds to the treatment, which is commonly referred to as 'efficacy'.
Patients may be invited to participate in Phase 1 or in Phase 2 depending on study doctor’s judgment.
With this application we submit 1 site in UK but Sponsor is looking at 2-3 new potential sites to be added to the study.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0453
Date of REC Opinion
4 Oct 2023
REC opinion
Further Information Favourable Opinion