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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 25, 2018
End Date:August 2021
Contact:Clinical Trial Manager
Email:clinical.trials@flxbio.com
Phone:650-489-9000

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

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.


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, breast cancer, urothelial carcinoma, gastric
cancer, colorectal adenocarcinoma, esophageal carcinoma, cervical cancer, ovarian
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
We found this trial at
10
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 443-287-6456
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-1612
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
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Atlanta, Georgia 30322
Phone: 404-727-3547
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Atlanta, GA
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Dallas, Texas 75246
Phone: 972-566-3000
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Dallas, TX
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-563-1930
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Los Angeles, California 90024
Phone: 310-794-3883
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Los Angeles, CA
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Nedlands, Western Australia
Phone: +61 (08) 6382 5100
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Nedlands,
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-737-5228
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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San Diego, California
Phone: 858-822-1962
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San Diego, CA
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