Summary

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

Description

Summary

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

Keywords

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

Eligibility

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

Locations

  • 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 not yet accepting patients
    Los Angeles California 90024 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FLX Bio, Inc.
ID
NCT03674567
Phase
Phase 1/2
Study Type
Interventional
Last Updated