Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab

Completed · Phase 1/Phase 2

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT03674567

Run by

RAPT Therapeutics, Inc.

People needed

323

Starts

2018-09-25

Expected to finish

2024-12-31

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 D.C., District of Columbia, United States
• Comprehensive Hematology and Oncology, LLC — St. 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
• Seoul National University — Seoul, South Korea

Full record on ClinicalTrials.gov

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