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

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
  • NTC 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
    Recruiting
  • Start Date
    September 25, 2018
  • Phase
    Phase 1/Phase 2
  • 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, including dose-limiting toxicities and maximum tolerated dose

Primary Outcome 1 - Timeframe: Approximately 18 weeks

Primary Outcome 2 - Measure: Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab

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

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, 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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: William Ho, MD, PhD

Role: Study Director

Affiliation: RAPT Therapeutics, Inc.

Overall Contact

Name: William Ho, MD, PhD

Phone: 650-489-9000

Email: clinical.trials@rapt.com

LOCATION

Facility Status Contact
Facility: University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California 90024
United States
Status: Recruiting Contact:
Ashlee Astacio
310-794-3883
AAstacio@mednet.ucla.edu
Facility: Yale Cancer Center
New Haven, Connecticut 06510
United States
Status: Recruiting Contact:
Caroline Hotchkins
203-737-5228
Facility: Comprehensive Hematology and Oncology, LLC
Saint Petersburg, Florida 33709
United States
Status: Recruiting Contact:
Gouri Deshpande
727-344-6569
gdeshpande@flhemonc.com
Facility: Emory Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact:
Chavon Porter
404-727-3547
chavon.porter@emoryhealthcare.org
Facility: University of Chicago
Chicago, Illinois 60637
United States
Status: Recruiting Contact:
Linda Janisch, RN
773-702-1612
ljanisch@medicine.bsd.uchicago.edu
Facility: Johns Hopkins University
Baltimore, Maryland 21231
United States
Status: Recruiting Contact:
Angela Scardina, RN
443-287-6456
ascardi2@jhmi.edu
Facility: Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact:
Ashley A McClain
704-947-6599
Facility: Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Status: Recruiting Contact:
Referral Office
972-566-3000
referral@marycrowley.org
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact:
Sarina Piha-Paul, MD
713-563-1930
spihapau@mdanderson.org
Facility: Linear Clinical Research Limited
Nedlands, Western Australia 6009
Australia
Status: Recruiting Contact:
Samantha Bowyer, MD
+61 (08) 6382 5100
Samantha.Bowyer@health.wa.gov.au