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 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)
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
Name: William Ho, MD, PhD
Role: Study Director
Affiliation: RAPT Therapeutics, Inc.
Name: Clinical Trial Manager
Phone: 650-489-9000
Email: clinical.trials@rapt.com
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 |