Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab
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.
Checked against the public recordLast updated Jan 24, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- RAPT Therapeutics, Inc.
- Interventions being studied
- Drug: FLX475; Drug: pembrolizumab (KEYTRUDA®)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner MD Anderson Cancer CenterGilbert, Arizona
- City of HopeDuarte, California
- University of California, Los Angeles JCCC Clinical Research UnitLos Angeles, California
- Yale Cancer CenterNew Haven, Connecticut
- Georgetown - Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Comprehensive Hematology and Oncology, LLCSt. Petersburg, Florida
- Moffitt Cancer CenterTampa, Florida
- Emory Winship Cancer InstituteAtlanta, Georgia
- University of ChicagoChicago, Illinois
- University of Louisville Hospital/James Graham Brown Cancer CenterLouisville, Kentucky
- Johns Hopkins UniversityBaltimore, Maryland
- Dana-Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 24, 2025. Always confirm current availability with the study team.