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TERMINATED
NCT04249843
PHASE1

Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors

Sponsor: MapKure, LLC

View on ClinicalTrials.gov

Summary

This Phase 1a/1b study evaluated the safety, pharmacokinetics, and preliminary antitumor activity of the investigational oral RAF dimer inhibitor BGB-3245 (brimarafenib) in participants with advanced or refractory solid tumors. Dose escalation evaluated safety/tolerability and informed dose selection. Dose expansion evaluated activity in molecularly defined tumor subsets

Official title: A First-in-Human, Phase 1a/1b, Open Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients With Advanced or Refractory Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

109

Start Date

2020-02-10

Completion Date

2025-08-08

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DRUG

Brimarafenib

administered orally (PO) once daily at doses specified in the description of each arm

Locations (9)

Cedars Sinai Medical Center

Beverly Hills, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD Anderson

Houston, Texas, United States

University of Virginia Comprehensive Cancer Centre

Charlottesville, Virginia, United States

Blacktown Hospital

Blacktown, New South Wales, Australia

The Kinghorn Cancer Centre, St Vincent Hospital Sydney

Sydney, New South Wales, Australia

One Clinical Research

Nedlands, Perth, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia