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Clinical Trial 20132

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03674567

Phase: Phase I/II
Prinicipal Investigator:

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Overview

Study Title

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

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.

Objective

Primary: To evaluate the safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced cancer; To evaluate the anti-tumor activity of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced solid tumors. Secondary: To define the maximum tolerated dose (MTD) and/or RP2D of FLX475, both as a single agent and in combination with pembrolizumab; To evaluate the PK profile of FLX475 alone and in combination with pembrolizumab; To assess the effects of FLX475 alone or in combination with pembrolizumab on PD markers relating to drug mechanism of action; To explore the relationships of PK and PD parameters to clinical drug activity; To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 alone or in combination with pembrolizumab

Treatments

Therapies

Medications

FLX475 (); Pembrolizumab (Keytruda)

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

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