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
NCT ID: NCT05668585
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
89 participants
INTERVENTIONAL
2022-12-08
2025-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Arm A: CFT1946
Approximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
CFT1946
Specified oral dose on specified day
Phase 1: Arm B: CFT1946 + trametinib
Approximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
CFT1946
Specified oral dose on specified day
Trametinib
Specified oral dose on specified day
Phase 2: Arm A1: CFT1946
Approximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
CFT1946
Specified oral dose on specified day
Phase 2: Arm B1: CFT1946 + trametinib
Approximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
CFT1946
Specified oral dose on specified day
Trametinib
Specified oral dose on specified day
Phase 1: Arm C: CFT1946 + cetuximab
Approximately 30 subjects with CRC (post BRAF inhibitor)
CFT1946
Specified oral dose on specified day
Cetuximab
Specified intravenous dose on specified day
Phase 2: Arm C1: CFT1946 + cetuximab
Approximately 40 subjects with CRC (post BRAF inhibitor)
CFT1946
Specified oral dose on specified day
Cetuximab
Specified intravenous dose on specified day
Interventions
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CFT1946
Specified oral dose on specified day
Trametinib
Specified oral dose on specified day
Cetuximab
Specified intravenous dose on specified day
Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥18 years of age at time of informed consent
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or liquid biopsy: (other protocol conditions may apply)
5. Subject must have received ≥1 prior line of SoC therapy for their unresectable locally advanced or metastatic disease with disease progression on or after last prior treatment. Prior regimens for these subjects vary by indication and investigational arm, but must have included the following:
1. Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior (neo)adjuvant immunotherapy may be acceptable.
2. CRC: Subjects must have received no more than 4 lines of prior therapy which includes systemic chemotherapy-based regimen per SoC for unresectable locally advanced or metastatic disease, and previous treatment with BRAF inhibitor in combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must have received at least 2 prior treatments. Subjects who received neo(adjuvant) chemotherapy regimens may be eligible.
3. ATC: Subjects must have received SoC therapy options including BRAF inhibitor if available and of benefit to the subject
4. Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC therapy options per their Investigator's best judgment, including BRAF inhibitor if available and of benefit to the subject
6. Subject has measurable disease per RECIST v1.1
7. Adequate bone marrow, liver, renal, and cardiac function
8. A female subject may be eligible if not pregnant, planning a pregnancy, not breast feeding, a women of non-child bearing potential or a WOCBP willing to comply with protocol conditions relating to the use contraception, ova or blood donation and pregnancy testing prior to the first dose
9. A male subject must agree to comply with protocol conditions relating to the use of contraception, sperm and blood donation
10. Subject can safely swallow a tablet or pill
Exclusion Criteria
2. Subject with CNS involvement (primary tumor or metastatic disease), except if clinically stable, have no evidence of new or enlarging brain metastases and are on stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects with untreated brain metastases may be eligible to enter without prior radiation therapy.
3. Subject with known malignancy other than trial indication that is progressing or has required treatment within the past 3 years, except for conditions that have undergone potentially curative therapy
4. Subject with history of thromboembolic or cerebrovascular events ≤6 months as defined in the protocol
5. Subject with impaired cardiac function or clinically significant cardiac disease, as defined in the protocol
6. Subject with history of uncontrolled diabetes mellitus (only for subjects who will receive CFT1946 + trametinib)
7. Subject with history or current evidence of retinal vein occlusion (RVO), chorioretinopathy, or current risk factors for RVO (only for subjects who will receive CFT1946 + trametinib)
8. Subject has received live, attenuated vaccine within 28 days prior to first dose administration
9. Subject has history of pneumonitis or interstitial lung disease
10. Subject has history of uveitis
11. Subject has clinically significant gastrointestinal abnormalities.
12. Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
13. Subject has history of or known HBV or active HCV infection
14. Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers, including any herbal medications/supplements
15. Subject has presence of Grade ≥2 toxicity due to prior cancer therapy, excepting alopecia and hypothyroidism requiring thyroid replacement therapy
16. Subject has initiation or receipt of the following ≤7 days prior to first dose administration: Hematopoietic colony-stimulating growth factors, transfusion of packed red blood cells (pRBC), and transfusion of platelets
17. Subject is pregnant, breastfeeding, or expecting to conceive or father children any time during the study
18 Years
ALL
No
Sponsors
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C4 Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Arizona - Cancer Center
Tucson, Arizona, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Allina Health System DBA Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Washington University School of Medicine
St 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, , France
Chu de Lille
Lille, , France
Centre Leon Berard
Lyon, , France
IUCT Oncopole
Toulouse, , France
KEM | Evang. Kliniken Essen-Mitte gGmbH
Essen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
NEXT Oncology Barcelona
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jiminez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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CFT1946-1101
Identifier Type: -
Identifier Source: org_study_id
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