for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion



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.

Official Title

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer


Advanced Cancer Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Breast Cancer Urothelial Carcinoma Gastric Cancer Pembrolizumab FLX475


You can join if…

Open to people ages 18 years and up

  • 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, breast cancer, urothelial carcinoma, gastric cancer, colorectal adenocarcinoma, esophageal carcinoma, cervical cancer, ovarian cancer, classical Hodgkin lymphoma
  • Dose Expansion: nasopharyngeal carcinoma, gastric cancer, EBV+ 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 CAN'T join 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


  • University of California, San Diego Moores Cancer Center not yet accepting patients
    San Diego California 92093 United States
  • University of California, Los Angeles JCCC Clinical Research Unit accepting new patients
    Los Angeles California 90024 United States


accepting new patients
Start Date
Completion Date
FLX Bio, Inc.
Phase 1/2
Study Type
Last Updated