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COMPLETED
NCT03674567
PHASE1/PHASE2

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

Sponsor: RAPT Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

323

Start Date

2018-09-25

Completion Date

2024-12-31

Last Updated

2026-09-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

FLX475 (tivumecirnon)

tablet

DRUG

pembrolizumab (KEYTRUDA®)

IV infusion

Locations (35)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles JCCC Clinical Research Unit

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Georgetown - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Comprehensive Hematology and Oncology, LLC

St. Petersburg, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Louisville Hospital/James Graham Brown Cancer Center

Louisville, Kentucky, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Quantum Santa Fe

Santa Fe, New Mexico, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Austin Hospital

Heidelberg, Victoria, Australia

Linear Clinical Research Limited

Nedlands, Western Australia, Australia

Queen Mary Hospital - Lymphoma

High West, Hong Kong

Queen Mary Hospital

High West, Hong Kong

Prince of Wales Hospital

Shatin, Hong Kong

Seoul National University

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Chungbuk National University Hospital

Taebuk, South Korea

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Meidcal Center

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

King Chulaongkorn Memorial Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand