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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FLX Bio, Inc.; RAPT Therapeutics, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

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