New targeted drug shows promise for BRAF-Mutant cancers in early trial

NCT ID NCT05668585

Disease control Sponsor: C4 Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called CFT1946, alone or with other drugs, in 89 adults with solid tumors that have a BRAF V600 mutation, including melanoma, lung, colon, and thyroid cancers. The main goals were to check safety and find the best dose. The study is complete, but results are not yet public.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CFT1946 (a targeted drug), trametinib, and cetuximab
What this could lead to: If successful, this could point toward a new treatment option for people with certain hard-to-treat cancers that have a BRAF V600 mutation.
What could go wrong: This is an early phase 1/2 trial with only 89 participants, so results are preliminary. The drug may not work as hoped or could have serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

89 people

The number who actually took part.

Started

Dec 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject (or legally authorized representative, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements 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 Other protocol defined exclusion criteria may apply Exclusion Criteria: 1. Subject has had major surgery within 21 days prior to the planned first dose. Minor surgery is permitted within 21 days prior to enrollment 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 Other protocol defined exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma melanoma non-small cell lung carcinoma thyroid gland undifferentiated (anaplastic) carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATC CRC Melanoma NSCLC Solid tumors

Contacts and locations

Locations

Allina Health System DBA Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States
Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom
Centre Leon Berard

Lyon, 69008, France
Chu de Lille

Lille, 59037, France
Community Health Network

Indianapolis, Indiana, 46250, United States
Complejo Hospitalario de Jaen

Jaén, 23007, Spain
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States
Florida Cancer Specialists

Sarasota, Florida, 34232, United States
Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain
Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain
IUCT Oncopole

Toulouse, 31059, France
Institut Bergonie

Bordeaux, 33076, France
KEM | Evang. Kliniken Essen-Mitte gGmbH

Essen, 45136, Germany
MD Anderson Cancer Center

Houston, Texas, 77030, United States
NEXT Oncology Barcelona

Barcelona, 08023, Spain
Sarah Cannon and HCA Research Institute

Nashville, Tennessee, 37203, United States
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jiminez Diaz

Madrid, 28040, Spain
The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom
Universitaetsklinikum Essen

Essen, 45147, Germany
University of Arizona - Cancer Center

Tucson, Arizona, 85719, United States
University of Wisconsin

Madison, Wisconsin, 53792, United States
Virginia Cancer Specialists (NEXT Oncology Virginia)

Fairfax, Virginia, 22031, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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