Study of DCC-3084 alone and with other cancer drugs in patients with advanced solid tumors driven by the MAPK pathway

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What is this study about?

This study focuses on patients with advanced solid tumors that are driven by changes in the MAPK pathway, which is a system that controls cell growth. The research examines a new medication called DCC-3084, which is given as a tablet that patients take by mouth. The study will test this medicine both alone and in combination with other cancer treatments.

The research aims to understand how safe and effective DCC-3084 is in treating different types of cancer, including non-small cell lung cancer, melanoma (skin cancer), pancreatic cancer, and prostate cancer. The study is divided into two parts – the first part finds the right dose of the medicine, while the second part tests how well the chosen dose works in treating cancer.

During the study, participants will receive DCC-3084 and undergo regular medical check-ups to monitor their health and how well the treatment is working. The medicine targets specific changes in cancer cells, particularly mutations in genes called KRAS, BRAF, HRAS, NRAS, CRAF, and NF1, which are known to be involved in cancer growth.

1 Initial evaluation

A medical assessment will confirm your eligibility for the study based on your solid tumor type and specific genetic mutations

Your overall health status will be evaluated using the ECOG Performance Status scale, which must be 0 or 1

Basic health checks will include organ function tests and electrolyte levels

If applicable, a pregnancy test will be performed

2 Treatment phase – Part 1 (Dose Escalation)

You will receive DCC-3084 tablets for oral use

The medication dose may be adjusted to determine the optimal amount

Regular evaluations will monitor any side effects

Your response to treatment will be assessed through imaging scans

3 Treatment phase – Part 2 (Dose Expansion)

If eligible for Part 2, you will receive DCC-3084 tablets at the established dose

Regular imaging scans will track your response to treatment

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

Treatment continues until disease progression or other stopping criteria are met

4 Monitoring and follow-up

Regular assessments will track your progress using imaging scans

Your survival and disease status will be monitored

Safety evaluations will continue throughout the study period

The study is expected to continue until January 2030

Who Can Join the Study?

Must be able to take medications by mouth
For women who can become pregnant, must have a negative pregnancy test before starting and agree to use appropriate birth control methods
Must have normal functioning organs and balanced body chemicals (electrolytes)
Must have good physical functioning ability, scoring 0 or 1 on the ECOG Performance Scale (a scale where 0 means fully active and 1 means restricted in physically strenuous activity but able to walk and do light work)
Must have a life expectancy of more than 6 months
For Part 1 participants: Must have confirmed solid cancer with specific genetic changes (KRAS, HRAS, NRAS, BRAF, CRAF, or NF1 mutations)
For Part 1 participants: Must have tried all available standard treatments for their condition without success
For Part 2 participants: Must have a confirmed BRAF gene mutation (a specific change in genetic material)
For Part 2 participants: Must have confirmation of disease progression after at least one previous treatment for advanced or spread cancer

Who Cannot Join the Study?

Patients under 18 years of age
Patients with active brain metastases (cancer that has spread to the brain) or uncontrolled spread of cancer to the brain
Patients with unstable heart conditions within the past 6 months, including heart attack, severe chest pain, or irregular heartbeat requiring treatment
Patients with uncontrolled high blood pressure despite medication
Pregnant or breastfeeding women
Patients participating in other clinical trials within 28 days before starting this study
Patients who received other cancer treatments within 4 weeks before starting this study
Patients with serious infections requiring intravenous antibiotics
Patients with impaired liver function (poor liver work)
Patients with impaired kidney function (poor kidney work)
Patients with known allergies to the study medication or similar drugs
Patients unable to swallow oral medications
Patients with conditions that might interfere with study procedures or results interpretation

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 Quironsalud Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Cgzsul Lwfz Budgcm	Lyon	France
Hvfjycta Vafx dzxymwri	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.08.2025
Germany	Not recruiting	01.08.2025
Spain	Not recruiting	01.08.2025

Trial locations

Investigated drugs:

DCC-3084

DCC-3084 is an investigational medication being studied for treating advanced cancers that are driven by changes in the MAPK pathway. This medication is being tested both as a standalone treatment and in combination with other cancer medications. It’s currently in early stages of research (Phase 1/2) to determine the right dose and evaluate how well it works in treating different types of cancer, including lung cancer, melanoma, pancreatic cancer, and prostate cancer.

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms solid tumors. It develops when cells in the lungs start growing abnormally and uncontrollably, affecting the MAPK pathway. The cancer typically grows and spreads more slowly than small cell lung cancer.

Melanoma – A form of skin cancer that develops in melanocytes, the cells that produce melanin. It typically appears as a new or changed mole on the skin and can be driven by mutations in the MAPK pathway. The cancer can develop anywhere on the body.

Pancreatic Ductal Adenocarcinoma (PDAC) – A cancer that forms in the ducts of the pancreas. It begins when cells in the pancreatic ducts develop mutations and grow uncontrollably, often involving the MAPK pathway. The cancer develops into solid tumors within the pancreatic tissue.

Castration-Resistant Prostate Cancer (CRPC) – A form of prostate cancer that continues to progress despite medical or surgical treatments that lower testosterone. It develops from regular prostate cancer when cancer cells adapt to grow despite low testosterone levels. The cancer typically involves changes in various signaling pathways, including MAPK.

Trial ID:

2024-517829-12-00

Protocol code:

DCC-3084-01-001

NCT ID:

NCT06287463

Trial Phase:

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

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Study of DCC-3084 alone and with other cancer drugs in patients with advanced solid tumors driven by the MAPK pathway

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?