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Brief Title: Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Official Title: Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Study ID: NCT03674567
Brief Summary: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope, Duarte, California, United States
University of California, Los Angeles JCCC Clinical Research Unit, Los Angeles, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgetown - Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Comprehensive Hematology and Oncology, LLC, Saint Petersburg, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
University of Louisville Hospital/James Graham Brown Cancer Center, Louisville, Kentucky, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Quantum Santa Fe, Santa Fe, New Mexico, United States
New York Presbyterian Hospital-Columbia University Medical Center, New York, New York, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Washington, Seattle, Washington, United States
Austin Hospital, Heidelberg, Victoria, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Queen Mary Hospital - Lymphoma, High West, , Hong Kong
Queen Mary Hospital, High West, , Hong Kong
Prince of Wales Hospital, Shatin, , Hong Kong
Chungbuk National University Hospital, Chungbuk, , Korea, Republic of
Seoul National University, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Meidcal Center, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
King Chulaongkorn Memorial Hospital, Bangkok, , Thailand
Ramathibodi Hospital, Bangkok, , Thailand
Name: William Ho, MD, PhD
Affiliation: RAPT Therapeutics, Inc.
Role: STUDY_DIRECTOR