Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
3 other identifiers
interventional
323
6 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2018
Longer than P75 for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedStudy Start
First participant enrolled
September 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 24, 2025
January 1, 2025
6.3 years
September 14, 2018
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose
Approximately 18 weeks
Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab
Through study completion (approximately 2 years)
Study Arms (4)
Part 1a: Monotherapy Dose Escalation
EXPERIMENTALEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
Part 1b: Combination Dose Escalation
EXPERIMENTALEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
Part 2a: Monotherapy Expansion Cohorts
EXPERIMENTALEligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.
Part 2b: Combination Expansion Cohorts
EXPERIMENTALEligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.
Interventions
tablet
IV infusion
Eligibility Criteria
You may qualify if:
- Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies
- Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma
- Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
- Tumor available for biopsy
You may not qualify if:
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
- Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
- Active graft-versus-host disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RAPT Therapeutics, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (35)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope
Duarte, California, 91010, United States
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California, 90024, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Georgetown - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Comprehensive Hematology and Oncology, LLC
St. Petersburg, Florida, 33709, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Quantum Santa Fe
Santa Fe, New Mexico, 87505, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, 6009, 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
Jungbuk, 28644, South Korea
Seoul National University
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Meidcal Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
King Chulaongkorn Memorial Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Ho, MD, PhD
RAPT Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 17, 2018
Study Start
September 25, 2018
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share