Breast Cancer Clinical Trial
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
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.
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
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
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There are 35 Locations for this study
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02215, United States
Santa Fe New Mexico, 87505, United States
Huntersville North Carolina, 28078, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Ulsan , 44033, Korea, Republic of
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