NCT05668585

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: C4 Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumors
• Melanoma
• NSCLC
• CRC
• ATC

Interventions

Type	Name	Description
DRUG	CFT1946	Specified oral dose on specified day
DRUG	Trametinib	Specified oral dose on specified day
DRUG	Cetuximab	Specified intravenous dose on specified day

Timeline

• Start date: 2022-12-08
• Primary completion: 2025-11-05
• Completion: 2025-11-05
• First posted: 2022-12-30
• Last updated: 2025-11-21

Locations

26 sites across 5 countries: United States, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study