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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)

Condition:

  • Advanced Cancer

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, 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

Email: clinical.trials@rapt.com

Locations

Facility Status Contact
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles, California 90024
United States
Recruiting Ashlee Astacio
310-794-3883
AAstacio@mednet.ucla.edu
Yale Cancer Center
New Haven, Connecticut 06510
United States
Recruiting Caroline Hotchkins
203-737-5228
Comprehensive Hematology and Oncology, LLC
Saint Petersburg, Florida 33709
United States
Recruiting Gouri Deshpande
727-344-6569
gdeshpande@flhemonc.com
Moffitt Cancer Center
Tampa, Florida 33612
United States
Not yet recruiting Neron Lewis
813-745-5247
neron.lewis@moffitt.org
Emory Winship Cancer Institute
Atlanta, Georgia 30322
United States
Recruiting Chavon Porter
404-727-3547
chavon.porter@emoryhealthcare.org
University of Chicago
Chicago, Illinois 60637
United States
Recruiting Linda Janisch, RN
773-702-1612
ljanisch@medicine.bsd.uchicago.edu
Johns Hopkins University
Baltimore, Maryland 21231
United States
Recruiting Angela Scardina, RN
443-287-6456
ascardi2@jhmi.edu
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Not yet recruiting DFCI Clinical Trials Hotline
1-877-DF-TRIAL
University of Michigan
Ann Arbor, Michigan 48109
United States
Not yet recruiting The Cancer Center Hotline
800-865-1125
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Recruiting Ashley A McClain
704-947-6599
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Recruiting Referral Office
972-566-3000
referral@marycrowley.org
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Sarina Piha-Paul, MD
713-563-1930
spihapau@mdanderson.org
Austin Hospital
Heidelberg, Victoria 3084
Australia
Not yet recruiting Sam Chakar
61 03 94963088
Linear Clinical Research Limited
Nedlands, Western Australia 6009
Australia
Recruiting Samantha Bowyer, MD
+61 (08) 6382 5100
Samantha.Bowyer@health.wa.gov.au
Queen Mary Hospital
High West,
Hong Kong
Not yet recruiting Joanne Wing Yan Chiu
852-2255 4249
jwychiu@hku.hk
Prince of Wales Hospital
Shatin,
Hong Kong
Not yet recruiting Brigette Buig Yue Ma
852-3505 1042
Brigette@clo.cuhk.edu.hk
Chungbuk National University Hospital
Chungbuk, 28644
Korea, Republic of
Not yet recruiting Ki Hyeong
82-43-269-6015
kihlee@chungbuk.ac.kr
Seoul National University
Seoul, 03080
Korea, Republic of
Not yet recruiting Tae Min Kim
82 2 2072 3559
tmgabriel7@gmail.com
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic of
Not yet recruiting Byoung Chul Cho
82-10-5212-8867
CBC1971@yuhs.ac
Asan Medical Center
Seoul, 05505
Korea, Republic of
Not yet recruiting Sung-Bae Kim
82-2-3010-3217
sbkim3@amc.seoul.kr
Ulsan University Hospital
Ulsan, 44033
Korea, Republic of
Not yet recruiting Young Joo Min
82-52-250-8832
yjmin65@gmail.com
National Cheng Kung University Hospital
Tainan, 70403
Taiwan
Not yet recruiting Wu-Chou Su
+886-6-235 3535
sunnysu@mail.ncku.edu.tw
Chi Mei Meidcal Center
Tainan, 71004
Taiwan
Not yet recruiting Yin-Hsun Feng
+886-6-281 2811
yinhsun.feng@gmail.com
National Taiwan University Hospital
Taipei, 10002
Taiwan
Not yet recruiting Chia-Chi Lin
+886-2-2312 3456
cclin1@ntu.edu.tw
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Not yet recruiting Muh-Hwa Yang
+886-2-2875 7270
mhyang2@vghtpe.gov.tw
King Chulaongkorn Memorial Hospital
Bangkok, 10330
Thailand
Not yet recruiting Virote Sriuranpong
668 6758 5502
virote.s@chula.ac.th
Ramathibodi Hospital
Bangkok, 10400
Thailand
Not yet recruiting Nuttapong Ngamphaiboon
668 4029 2822
nuttapong.nga@mahidol.ac.th
Siriraj Hospital
Bangkok, 10700
Thailand
Not yet recruiting Nopadol Soparattanapaisarn
668 6587 0900
nsopa99@gmail.com