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

Purpose

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.

Condition

  • Advanced Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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, 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1a: Monotherapy Dose Escalation 		Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
  • Drug: FLX475
    tablet
Experimental
Part 1b: Combination Dose Escalation 		Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
  • Drug: FLX475
    tablet
  • Drug: pembrolizumab (KEYTRUDA®)
    IV infusion
Experimental
Part 2a: Monotherapy Expansion Cohorts 		Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.
  • Drug: FLX475
    tablet
Experimental
Part 2b: Combination Expansion Cohorts 		Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.
  • Drug: FLX475
    tablet
  • Drug: pembrolizumab (KEYTRUDA®)
    IV infusion

More Details

Status
Active, not recruiting
Sponsor
RAPT Therapeutics, Inc.

Study Contact