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Brief Title: Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies
Official Title: A First-In-Human, Phase 1/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies
Study ID: NCT04521413
Brief Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Detailed Description: This study will be a first-in-human study evaluating the safety and tolerability of CFI-402411 in subjects with advanced solid malignancies, when CFI-402411 is administered as a single agent or in combination with pembrolizumab. CFI-402411 is an oral pill that blocks the function of HPK1. Blocking HPK1 could stimulate an immune response against the tumor in patients. This immune response could be further enhanced when combined with pembrolizumab. The data obtained from this study will determine the dose and schedule and subject selection for further clinical studies. Pre-clinical findings support further development of CFI-402411 as a novel anti-cancer agent, and the combination of CFI-402411 with pembrolizumab as a potential strategy to improve outcomes of subjects with advanced malignancies.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, La Jolla, California, United States
The Angeles Clinic, Los Angeles, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Florida Cancer Specialists, Sarasota, Florida, United States
START - Mid-West, Grand Rapids, Michigan, United States
SCRI - Nashville, Nashville, Tennessee, United States
MD Anderson, Houston, Texas, United States
START - San Antonio, San Antonio, Texas, United States
Virginia Cancer Specialist, Fairfax, Virginia, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Prince of Wales Hospital, Sha Tin, , Hong Kong
Name: Omid Hamid, Dr
Affiliation: The Angeles Clinic, Los Angeles
Role: PRINCIPAL_INVESTIGATOR