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

  • Interventional
  • Recruiting
  • NCT03674567
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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, 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

        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

At a Glance

National Government IDNCT03674567

IRB#IRB18-1199

Lead SponsorRAPT Therapeutics, Inc.

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting