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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

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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

DCC-3084 - An investigational anticancer drug being studied in clinical trials for treating solid tumors driven by the MAPK pathway. The medication is being evaluated both as a monotherapy and in combination with other anticancer agents, with a focus on treating various types of cancer including non-small cell lung cancer (NSCLC), melanoma, pancreatic cancer, and castration-resistant prostate cancer. Currently in Phase 1/2 clinical trials, this drug is administered to assess its safety, tolerability, and effectiveness in treating advanced malignancies. The primary mechanism of action involves targeting the MAPK pathway, which plays a crucial role in cell growth and survival in many types of cancer.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517829-12-00Protocol codeDCC-3084-01-001Estimated enrolment128 patientsSponsorDeciphera Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).