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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
RAPT Therapeutics, Inc.
Study ID
NCT03674567
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FLX475 (tivumecirnon) — DRUG
    tablet
  • pembrolizumab (KEYTRUDA®) — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Sep 17, 2018
Start date
Sep 25, 2018
Status verified
Aug 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
323 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a: Monotherapy Dose Escalation
    Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
  • Experimental: Part 1b: Combination Dose Escalation
    Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
  • Experimental: Part 2a: Monotherapy Expansion Cohorts
    Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.
  • Experimental: Part 2b: Combination Expansion Cohorts
    Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.

Primary Outcome 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 [ Time Frame: Approximately 18 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
City of HopeDuarteCalifornia91010-
University of California, Los Angeles JCCC Clinical Research UnitLos AngelesCalifornia90024-
Yale Cancer CenterNew HavenConnecticut06510-
Georgetown - Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Comprehensive Hematology and Oncology, LLCSt. PetersburgFlorida33709-
Moffitt Cancer CenterTampaFlorida33612-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
University of Louisville Hospital/James Graham Brown Cancer CenterLouisvilleKentucky40202-
Johns Hopkins UniversityBaltimoreMaryland21231-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
Quantum Santa FeSanta FeNew Mexico87505-
New York Presbyterian Hospital-Columbia University Medical CenterNew YorkNew York10032-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Mary Crowley Cancer Research CenterDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of WashingtonSeattleWashington98195-

Related coverage on Hipa.ai

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope· Duarte, CAUniversity of California, Los Angeles JCCC Clinical Research Unit· Los Angeles, CAYale Cancer Center· New Haven, CTGeorgetown - Lombardi Comprehensive Cancer Center· Washington D.C., DCComprehensive Hematology and Oncology, LLC· St. Petersburg, FL

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