Spots Global Cancer Trial Database for First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
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Trial Identification
Brief Title: First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Official Title: A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors
Study ID: NCT05759949
Study Description
Brief Summary: This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States
Community Cancer Center North, Indianapolis, Indiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center-Main Campus, New York, New York, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Contact Details
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