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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.