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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
C4 Therapeutics, Inc.
Study ID
NCT05668585
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CFT1946 — DRUG
    Specified oral dose on specified day
  • Trametinib — DRUG
    Specified oral dose on specified day
  • Cetuximab — DRUG
    Specified intravenous dose on specified day

Study Details

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).

Key Dates

Start date
Dec 8, 2022
Status verified
Nov 2025
Primary completion
Nov 5, 2025
Completion
Nov 5, 2025

Study Design

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

Arms

  • Experimental: Phase 1: Arm A: CFT1946
    Approximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
  • Experimental: Phase 1: Arm B: CFT1946 + trametinib
    Approximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
  • Experimental: Phase 2: Arm A1: CFT1946
    Approximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
  • Experimental: Phase 2: Arm B1: CFT1946 + trametinib
    Approximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
  • Experimental: Phase 1: Arm C: CFT1946 + cetuximab
    Approximately 30 subjects with CRC (post BRAF inhibitor)
  • Experimental: Phase 2: Arm C1: CFT1946 + cetuximab
    Approximately 40 subjects with CRC (post BRAF inhibitor)

Primary Outcome Measure

Frequency and severity of AEs and SAEs [ Time Frame: From enrollment until 30 days after completion of study treatment ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of Arizona - Cancer CenterTucsonArizona85719-
Florida Cancer SpecialistsSarasotaFlorida34232-
Community Health NetworkIndianapolisIndiana46250-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Allina Health System DBA Virginia Piper Cancer InstituteMinneapolisMinnesota55407-
Washington University School of MedicineSt LouisMissouri63110-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Sarah Cannon and HCA Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer Specialists (NEXT Oncology Virginia)FairfaxVirginia22031-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Tucson, AZ

By condition
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OncologySkin cancerDermatologyLung oncologyLung disease
By research site
University of Arizona - Cancer Center· Tucson, AZFlorida Cancer Specialists· Sarasota, FLCommunity Health Network· Indianapolis, INDana-Farber Cancer Institute· Boston, MAAllina Health System DBA Virginia Piper Cancer Institute· Minneapolis, MNWashington University School of Medicine· St Louis, MO

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