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Study of CFT1946 alone and with trametinib or cetuximab in patients with BRAF-V600 mutant solid tumors who have received standard treatment

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with BRAF-V600 mutant solid tumors, which include melanoma, non-small cell lung cancer, colorectal cancer, and anaplastic thyroid carcinoma. These types of cancers have a specific change (mutation) in a gene called BRAF that affects how cancer cells grow and spread.

The study will test a new medication called CFT1946, which will be given either alone or in combination with other cancer medicines - trametinib or cetuximab. CFT1946 is taken as a tablet by mouth, while cetuximab is given through an infusion into a vein. The purpose is to understand how safe these treatments are and how well they work in treating these types of cancers.

During the study, patients will receive either CFT1946 by itself or combined with one of the other medications. Doctors will monitor patients' health regularly through various medical examinations and tests to check how well the treatment is working and to watch for any side effects. The study is divided into two parts - the first part focuses on finding the right dose and checking safety, while the second part looks at how effective the treatment is in fighting the cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo evaluation to confirm your eligibility for the study, including verification of your BRAF-V600 mutant solid tumor.

    Your medical history and previous treatments will be reviewed to ensure you meet the study requirements.

    Basic health assessments will check your bone marrow, liver, renal, and cardiac function.

  2. Step 2

    Treatment assignment

    Based on your specific tumor type, you will be assigned to one of the treatment groups:

    - CFT1946 alone (taken as tablets by mouth)

    - CFT1946 combined with trametinib (both taken as tablets by mouth)

    - CFT1946 combined with cetuximab (CFT1946 as tablets by mouth, cetuximab as infusion)

  3. Step 3

    Treatment period

    You will take the prescribed medication according to the dosing schedule provided by your doctor.

    Regular assessments will monitor your tumor response using imaging scans.

    Safety evaluations will track any side effects or changes in your health.

    Blood samples will be collected to measure drug levels in your body.

  4. Step 4

    Ongoing monitoring

    Your tumor response will be measured using standard imaging criteria (RECIST v1.1).

    Regular health checks will continue throughout the study period.

    The study team will monitor and record any side effects.

    Dose adjustments may be made if needed based on your response and tolerance.

  5. Step 5

    Study completion

    The study will continue until October 2026 or earlier if specified study endpoints are reached.

    Final assessments will evaluate your overall response to treatment.

    Documentation of your tumor response and safety outcomes will be completed.

Who can join the trial?

11 criteria

  • Must be at least 18 years old
  • Must be able to provide informed consent and follow study requirements
  • Must have a BRAF-V600 mutant solid tumor (a specific genetic change in the tumor) which can include: - Melanoma (skin cancer) - Non-small cell lung cancer - Colorectal cancer (cancer of the large intestine) - Anaplastic thyroid cancer
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale (able to perform daily activities with minimal assistance)
  • Must have received at least one previous standard treatment for advanced or spreading cancer, with the disease getting worse during or after treatment
  • Must have measurable disease that can be evaluated using specific imaging criteria (RECIST v1.1)
  • Must have adequate function of: - Bone marrow - Liver - Kidneys - Heart
  • Must be able to swallow tablets or pills
  • For women: Must not be pregnant, planning pregnancy, or breastfeeding. Must use appropriate contraception if able to become pregnant
  • For men: Must agree to use contraception and follow study requirements regarding sperm and blood donation
  • Specific previous treatment requirements apply based on cancer type and study group assignment

Who cannot join the trial?

14 criteria

  • History of allergic reactions to similar medications (BRAF inhibitors or related compounds)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions or uncontrolled high blood pressure
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials or treatment with experimental drugs within the past 30 days
  • Serious infections, including active HIV, hepatitis B, or hepatitis C
  • Major surgery within 4 weeks before starting the trial
  • Significant liver or kidney problems
  • Previous treatment with similar targeted therapies that resulted in serious side effects
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to swallow oral medications
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Mental conditions that could interfere with following study procedures
  • Life expectancy less than 3 months
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Investigated drugs

  • CFT1946

    is an investigational medication being studied for treating solid tumors that have a specific genetic mutation called BRAF-V600. This medication is being tested both alone and in combination with other drugs to determine how safe and effective it is for cancer treatment.

  • Trametinib

    is a medication that works by blocking certain proteins that can cause cancer cells to grow. In this trial, it is being tested in combination with CFT1946 to see if the two medications work better together in treating tumors.

  • Cetuximab

    is an antibody medication that targets a specific protein on cancer cells called EGFR (epidermal growth factor receptor). In this trial, it is being studied in combination with CFT1946 to evaluate their combined effectiveness in treating cancer.

What is already known about the treatment

  • CFT1946

    An investigational drug being studied in clinical trials for the treatment of various BRAF-V600 mutant solid tumors, including melanoma, non-small cell lung cancer, colorectal cancer, and anaplastic thyroid carcinoma. The medication is being evaluated both as a monotherapy and in combination with trametinib or cetuximab for patients who have already received standard care treatments. CFT1946 is currently in Phase 1/2 clinical trials to determine its safety profile, optimal dosing, and preliminary effectiveness in treating these types of cancers.

  • Trametinib

    A targeted therapy medication used in combination with CFT1946 in clinical trials for treating BRAF-V600 mutant solid tumors. It belongs to the class of drugs known as MEK inhibitors and works by blocking specific proteins that promote cancer cell growth. Trametinib is already approved for use in certain types of cancer treatment and is being studied in this new combination to potentially enhance therapeutic outcomes.

  • Cetuximab

    A monoclonal antibody medication being tested in combination with CFT1946 for treating BRAF-V600 mutant solid tumors. It works by targeting and blocking the epidermal growth factor receptor (EGFR) on cancer cells, which helps slow or stop tumor growth. Cetuximab is an established cancer treatment that is now being evaluated in this new combination therapy approach to potentially improve treatment outcomes.

Investigated diseases

  • Melanoma

    A type of skin cancer that develops from melanocytes, the cells that produce melanin pigment. It typically appears as a new or changed mole on the skin, showing irregular borders, varying colors, and asymmetrical shape.

  • Non-small cell lung cancer

    A common form of lung cancer that begins in the cells lining the airways and air sacs of the lungs. The cancer cells grow and form tumors that can spread to other parts of the body.

  • Colorectal cancer

    A cancer that starts in either the colon or rectum, usually developing from small growths called polyps. It develops when cells in the colon or rectum begin to grow uncontrollably.

  • Anaplastic thyroid carcinoma

    A rare form of thyroid cancer that develops in the thyroid gland. The cancer cells in this type grow rapidly and do not look like normal thyroid cells under a microscope.

  • BRAF-V600 Mutant Solid Tumors

    Solid tumors characterized by a specific mutation in the BRAF gene, known as V600. This genetic change affects how cells grow and divide, leading to the development of various types of cancer.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-501618-70-00Protocol codeCFT1946-1101Estimated enrolment183 patientsSponsorC4 Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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