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

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

INTRODUCTION

  • Org Study ID: FLX475-02
  • Secondary ID: N/A
  • NCT ID: NCT03674567
  • Sponsor: RAPT Therapeutics, Inc.

BRIEF 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.

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.

  • Overall Status
    Completed
  • Start Date
    September 25, 2018
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events

Primary Outcome 1 - Timeframe: Approximately 18 weeks

Primary Outcome 2 - Measure: including dose-limiting toxicities and maximum tolerated dose

Primary Outcome 2 - Timeframe: Through study completion (approximately 2 years)

Primary Outcome 3 - Measure: Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab

Primary Outcome 3 - Timeframe: N/A

CONDITION

  • Advanced Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: William Ho, MD, PhD

Role: Study Director

Affiliation: RAPT Therapeutics, Inc.

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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