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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario De Jaen	Jaen	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Ucxnmepvjujpkxgcqpzto Egyao Alq	Essen	Germany
Ixkwclle Biogcxlf	Bordeaux	France
Aylztxl Uewkb Shkijmlgu Loxchq Dj Bmqojik	Bologna	Italy
Ckeinr Llwz Bvbrlz	Lyon	France
Kmytxdev Ejigmatdjcsvdwvzvwkhvnni Hgmupyfgtalxpzonl	Essen	Germany
Hltwvawj Vcvq dizgknmq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.06.2023
Germany	Not recruiting	30.06.2023
Italy	Not recruiting	30.06.2023
Spain	Not recruiting	30.06.2023

Trial locations

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.

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 ID:

2022-501618-70-00

Protocol code:

CFT1946-1101

NCT ID:

NCT05668585

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?