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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

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Linear Clinical Research Limited
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NedlandsAustraliaUnknown status
Queen Mary Hospital - Lymphoma
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High WestHong Kong SAR ChinaUnknown status
Queen Mary Hospital
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High WestHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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ShatinHong Kong SAR ChinaUnknown status
Chungbuk National University Hospital
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JungbukSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Ramathibodi Hospital
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BangkokThailandUnknown status
King Chulaongkorn Memorial Hospital
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BangkokThailandUnknown status
Chi Mei Meidcal Center
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TainanTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
Emory Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Mary Crowley Cancer Research Center
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DallasUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Carolina Biooncology Institute
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HuntersvilleUnited StatesUnknown status
University of California, Los Angeles JCCC Clinical Research Unit
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Los AngelesUnited StatesUnknown status
University of Louisville Hospital/James Graham Brown Cancer Center
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LouisvilleUnited StatesUnknown status
Yale Cancer Center
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New HavenUnited StatesUnknown status
New York Presbyterian Hospital-Columbia University Medical Center
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New YorkUnited StatesUnknown status
Quantum Santa Fe
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Santa FeUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Comprehensive Hematology and Oncology, LLC
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St. PetersburgUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Georgetown Lombardi Comprehensive Cancer Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.