NCT03674567CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 323 (actual)
- First submitted
- 14 Sept 2018
- Start date
- 25 Sept 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- NCT number
- NCT03674567
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 323
- From 25 Sept 2018 to the primary completion date, 31 Dec 2024
- 35 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
Other illness
- History of allergy or severe hypersensitivity to biologic agents
- 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
- Active graft-versus-host disease
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Linear Clinical Research Limited Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Queen Mary Hospital - Lymphoma Coordinator of this site? Confirm its status | High West | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | High West | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Jungbuk | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| King Chulaongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chi Mei Meidcal Center Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Mary Crowley Cancer Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Carolina Biooncology Institute Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| University of California, Los Angeles JCCC Clinical Research Unit Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Louisville Hospital/James Graham Brown Cancer Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| New York Presbyterian Hospital-Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Quantum Santa Fe Coordinator of this site? Confirm its status | Santa Fe | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Comprehensive Hematology and Oncology, LLC Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown Lombardi Comprehensive Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.