Clinical Trials /

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

NCT03674567

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Cervical Carcinoma
  • Classical Hodgkin Lymphoma
  • Colorectal Adenocarcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma
  • Nasopharyngeal Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
  • Official Title: Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: FLX475-02
  • NCT ID: NCT03674567

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
FLX475Part 1a: Monotherapy Dose Escalation
PembrolizumabKeytrudaPart 1b: Combination Dose Escalation

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1a: Monotherapy Dose EscalationExperimentalEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
  • FLX475
Part 1b: Combination Dose EscalationExperimentalEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
  • FLX475
  • Pembrolizumab
Part 2a: Monotherapy Expansion CohortsExperimentalEligible 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.
  • FLX475
Part 2b: Combination Expansion CohortsExperimentalEligible 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.
  • FLX475
  • Pembrolizumab

Eligibility Criteria

        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, breast cancer, urothelial carcinoma, gastric
                  cancer, colorectal adenocarcinoma, esophageal carcinoma, cervical cancer, ovarian
                  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose
Time Frame:Approximately 18 weeks
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:FLX Bio, Inc.

Trial Keywords

  • Non-small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Breast Cancer
  • Urothelial Carcinoma
  • Gastric Cancer

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