A Phase 1 Study of CFT1946 in People With Solid Tumors Containing Mutations in BRAF-V600

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Full 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

Purpose

A change in a gene called BRAF-V600 can promote the growth of some cancers. CFT1946 is a drug that destroys proteins made by the mutated BRAF-V600 gene. This action may slow or stop cancer growth. In this study, researchers are seeking the highest dose of CFT1946 that can be given alone and with the drug trametinib. The people in this study will have advanced solid tumors that contain a BRAF-V600 mutation. Both medications are taken orally (by mouth).

Who Can Join

Eligibility:

To take part in this study, patients must meet several requirements, including:

  • Participants must have a solid tumor that has spread despite prior treatment.
  • Patients’ tumors must contain a BRAF-V600 mutation.
  • The serious side effects of prior therapies must go away before the study treatment is given.
  • Patients must be physically well enough that they can be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could do office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to see if you may be able to be in this study, please contact the office of Dr. Ezra Rosen at 646-888-6955.

Protocol

23-091

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05668585