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Brief Title: A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
Official Title: A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
Study ID: NCT05668585
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm B) or Cetuximab (CFT1946 + cetuximab; Arm C).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Cancer Specialists, Sarasota, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists (NEXT Oncology Virginia), Fairfax, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Institut Bergonie, Bordeaux Cedex, , France
Chu de Lille, Lille, , France
Centre Leon Berard, Lyon, , France
IUCT Oncopole, Toulouse, , France
NEXT Oncology Barcelona, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jiminez Diaz, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain