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Cft1946

A groundbreaking clinical trial is underway to investigate the potential of CFT1946, a novel drug targeting BRAF V600 mutant solid tumors. This study aims to evaluate the safety, tolerability, and preliminary efficacy of CFT1946 as both a monotherapy and in combination with other drugs. The trial focuses on patients with various types of solid tumors, including melanoma, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and anaplastic thyroid cancer (ATC).

Table of Contents

What is CFT1946?

CFT1946 is a new drug being studied for the treatment of certain types of cancer[1]. It is specifically designed to target cancers that have a particular genetic mutation called BRAF V600. This mutation is found in several types of solid tumors, which are abnormal masses of tissue that don’t contain cysts or liquid areas.

What conditions does CFT1946 target?

The clinical trial is focusing on several types of cancers that have the BRAF V600 mutation[1]:

  • Melanoma: A type of skin cancer that develops in cells that produce melanin, the pigment that gives skin its color.
  • NSCLC (Non-Small Cell Lung Cancer): A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope.
  • CRC (Colorectal Cancer): Cancer that starts in the colon or rectum.
  • ATC (Anaplastic Thyroid Cancer): A rare and aggressive type of thyroid cancer.

How does CFT1946 work?

CFT1946 is designed to target and degrade the BRAF V600 protein in cancer cells[1]. The BRAF gene normally helps control cell growth, but when it’s mutated (as in BRAF V600), it can cause cells to grow and divide too quickly, leading to cancer. By degrading this mutated protein, CFT1946 aims to slow down or stop the growth of cancer cells.

Current Clinical Trial

A clinical trial is currently underway to study CFT1946[1]. This trial is divided into two phases:

Phase 1:

  • Aims to determine the safety and the right dose of CFT1946.
  • Includes patients with various solid tumors that have the BRAF V600 mutation.
  • Some patients will receive CFT1946 alone, while others will receive it in combination with other drugs.

Phase 2:

  • Focuses on how well CFT1946 works in treating specific types of cancer.
  • Includes patients with melanoma, non-small cell lung cancer, and colorectal cancer.
  • Some patients will receive CFT1946 alone, while others will receive it in combination with other drugs.

Combination Therapies

The study is also looking at how CFT1946 works when combined with other cancer treatments[1]:

  • CFT1946 + Trametinib: Trametinib is another drug that targets a different part of the same cellular pathway as CFT1946. This combination is being tested in patients with melanoma and non-small cell lung cancer.
  • CFT1946 + Cetuximab: Cetuximab is a type of targeted therapy that works differently from CFT1946. This combination is being tested specifically in patients with colorectal cancer.

Safety and Efficacy Evaluation

The main goals of this study are to evaluate how safe CFT1946 is and how well it works[1]. Researchers will be looking at several factors:

  • Side effects: The frequency and severity of adverse events (side effects) will be closely monitored.
  • Dose adjustments: How often the dose needs to be changed or interrupted due to side effects.
  • Treatment response: How many patients see their tumors shrink or stop growing (overall response rate and disease control rate).
  • Duration of response: How long the treatment continues to work for patients who respond.
  • Progression-free survival: How long patients live without their cancer getting worse.

Potential Benefits for Patients

While it’s important to remember that CFT1946 is still in the testing phase, it shows promise for several reasons[1]:

  • Targeted therapy: By focusing on a specific genetic mutation, CFT1946 may be more effective and potentially have fewer side effects than some traditional cancer treatments.
  • New option for resistant cancers: The study includes patients whose cancer has continued to grow despite previous treatment with BRAF inhibitors, offering a potential new option for these patients.
  • Combination potential: By studying CFT1946 in combination with other drugs, researchers hope to find more effective treatment strategies for different types of cancer.

It’s important to note that as this is an ongoing clinical trial, the full benefits and risks of CFT1946 are not yet known. Patients interested in this treatment should discuss it with their healthcare provider to understand if it might be appropriate for their specific situation.

Aspect Details
Study Drug CFT1946
Target Population Patients with BRAF V600 mutant solid tumors
Cancer Types Melanoma, NSCLC, CRC, ATC
Study Arms CFT1946 monotherapy, CFT1946 + trametinib, CFT1946 + cetuximab
Primary Outcomes Safety, tolerability, MTD, RP2D, overall response rate
Secondary Outcomes Pharmacokinetics, disease control rate, progression-free survival, duration of response
Study Duration Up to approximately 43 months

FAQ

  • What is the main purpose of the CFT1946 clinical trial? The main purpose is to evaluate the safety and tolerability of CFT1946, determine the maximum tolerated dose, and find the recommended Phase 2 dose for CFT1946 alone and in combination with other drugs.
  • What types of cancer does this trial focus on? The trial focuses on solid tumors with BRAF V600 mutations, including melanoma, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and anaplastic thyroid cancer (ATC).
  • How is CFT1946 administered in the trial? CFT1946 is administered orally at a specified dose on specified days throughout the trial.
  • What other drugs are being tested in combination with CFT1946? The trial is testing CFT1946 in combination with trametinib (taken orally) and cetuximab (given intravenously).
  • How long will patients be monitored during the trial? Patients will be monitored for safety outcomes up to 30 days after completing the study treatment, and for efficacy outcomes for up to approximately 43 months.

Ongoing Clinical Trials on Cft1946

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

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany Italy Spain

Glossary

  • BRAF V600 Mutation: A specific change in the BRAF gene that can lead to increased cell growth and cancer development. This mutation is common in certain types of cancer, including melanoma.
  • Solid Tumor: An abnormal mass of tissue that doesn't contain cysts or liquid areas. Solid tumors may be benign (not cancerous) or malignant (cancerous).
  • Monotherapy: Treatment using a single drug or method.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that doesn't cause unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug recommended for use in Phase 2 clinical trials, based on results from Phase 1 studies.
  • NSCLC: Non-Small Cell Lung Cancer, a type of lung cancer that is the most common form of the disease.
  • CRC: Colorectal Cancer, a type of cancer that starts in the colon or rectum.
  • ATC: Anaplastic Thyroid Cancer, a rare and aggressive form of thyroid cancer.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): Any adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • CTCAE: Common Terminology Criteria for Adverse Events, a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action.

References