Spots Global Cancer Trial Database for First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
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Trial Identification
Brief Title: First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
Official Title: A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
Study ID: NCT05216432
Study Description
Brief Summary: This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors, RLY-2608 + fulvestrant and RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) combination arms for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 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
The University of Arizona Cancer Center, Tucson, Arizona, United States
HealthONE, Denver, Colorado, United States
Florida Cancer Specialists, Orlando, Florida, United States
Boca Raton Clinical Research (BRCR) Global, Plantation, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
NEXT Virginia, Fairfax, Virginia, United States
UW Carbone Cancer Center, Madison, Wisconsin, United States
Gustave Roussy, Villejuif, , France
Istituto Europeo di Oncologia IRCCS, Milano, , Italy
Vall d'Hebron Instituto de Oncologia, Barcelona, , Spain
Institut Catala D'Oncologia - Badalona (ICO Badalona), Barcelona, , Spain
START Madrid - Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Contact Details
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