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

NCT03674567

CompletedPhase 1, Phase 2

Sponsor: RAPT Therapeutics, Inc.

Conditions: Advanced Cancer

Interventions: FLX475 (tivumecirnon), pembrolizumab (KEYTRUDA®)

Countries: United States, Australia, Hong Kong, South Korea, Taiwan, Thailand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (35)
  • Gilbert, Arizona, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Santa Fe, New Mexico, United States
  • New York, New York, United States
  • Huntersville, North Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Heidelberg, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • High West, Hong Kong
  • High West, Hong Kong
  • Shatin, Hong Kong
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Taebuk, South Korea
  • Tainan, Taiwan
  • + 5 more on CT.gov