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
Study of BLU-222 Alone or in Combination with Other Cancer Therapy for Patients with Advanced Cancer
Sponsor: Blueprint Medicines Corporation
Enrolling: Male and Female Patients
IRB Number: AAAU0605
U.S. Govt. ID: NCT05252416
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) 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 (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects 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 subjects to identify the recommended dose. 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. Cancers include: bladder cancer, breast cancer, colon and rectal cancer, esophageal cancer, gynecologic cancers, head and neck/oral cancer, kidney cancer, liver cancer, lung cancer, pancreatic cancer, prostate cancer, stomach cancer, and thyroid cancer.
Investigator
Julia McGuinness, MD
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Are you at least 18 years old? Yes No
Are you able to swallow oral medication whole? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162