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BRIEF TITLE: Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer

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

  • Org Study ID: FLX475-02
  • Secondary ID:
  • NCT ID: NCT03674567
  • NCT Alias:
  • Sponsor: RAPT Therapeutics, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting September 25, 2018 Phase 1/Phase 2 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 - Time Frame: 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 - Time Frame: Through study completion (approximately 2 years)


  • Advanced Cancer


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
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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: Clinical Trial Manager

Phone: 650-489-9000



Facility Status Contact
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California 90024
United States
Recruiting Ashlee Astacio
Yale Cancer Center
New Haven, Connecticut 06510
United States
Recruiting Caroline Hotchkins
Comprehensive Hematology and Oncology, LLC
Saint Petersburg, Florida 33709
United States
Recruiting Gouri Deshpande
Moffitt Cancer Center
Tampa, Florida 33612
United States
Not yet recruiting Neron Lewis
Emory Winship Cancer Institute
Atlanta, Georgia 30322
United States
Recruiting Chavon Porter
University of Chicago
Chicago, Illinois 60637
United States
Recruiting Linda Janisch, RN
Johns Hopkins University
Baltimore, Maryland 21231
United States
Recruiting Angela Scardina, RN
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Not yet recruiting DFCI Clinical Trials Hotline
University of Michigan
Ann Arbor, Michigan 48109
United States
Not yet recruiting The Cancer Center Hotline
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Recruiting Ashley A McClain
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Recruiting Referral Office
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Sarina Piha-Paul, MD
Austin Hospital
Heidelberg, Victoria 3084
Not yet recruiting Sam Chakar
61 03 94963088
Linear Clinical Research Limited
Nedlands, Western Australia 6009
Recruiting Samantha Bowyer, MD
+61 (08) 6382 5100
Queen Mary Hospital
High West,
Hong Kong
Not yet recruiting Joanne Wing Yan Chiu
852-2255 4249
Prince of Wales Hospital
Hong Kong
Not yet recruiting Brigette Buig Yue Ma
852-3505 1042
Chungbuk National University Hospital
Chungbuk, 28644
Korea, Republic of
Not yet recruiting Ki Hyeong
Seoul National University
Seoul, 03080
Korea, Republic of
Not yet recruiting Tae Min Kim
82 2 2072 3559
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic of
Not yet recruiting Byoung Chul Cho
Asan Medical Center
Seoul, 05505
Korea, Republic of
Not yet recruiting Sung-Bae Kim
Ulsan University Hospital
Ulsan, 44033
Korea, Republic of
Not yet recruiting Young Joo Min
National Cheng Kung University Hospital
Tainan, 70403
Not yet recruiting Wu-Chou Su
+886-6-235 3535
Chi Mei Meidcal Center
Tainan, 71004
Not yet recruiting Yin-Hsun Feng
+886-6-281 2811
National Taiwan University Hospital
Taipei, 10002
Not yet recruiting Chia-Chi Lin
+886-2-2312 3456
Taipei Veterans General Hospital
Taipei, 11217
Not yet recruiting Muh-Hwa Yang
+886-2-2875 7270
King Chulaongkorn Memorial Hospital
Bangkok, 10330
Not yet recruiting Virote Sriuranpong
668 6758 5502
Ramathibodi Hospital
Bangkok, 10400
Not yet recruiting Nuttapong Ngamphaiboon
668 4029 2822
Siriraj Hospital
Bangkok, 10700
Not yet recruiting Nopadol Soparattanapaisarn
668 6587 0900