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DCC-3084

DCC-3084 is an investigational drug currently being studied in clinical trials for patients with advanced cancers that are driven by the MAPK pathway. This multicenter, Phase 1/2 clinical trial is evaluating DCC-3084 both as a standalone treatment and in combination with other cancer therapies. The study primarily focuses on patients with advanced or metastatic solid tumors, with a particular interest in specific cancer types including non-small cell lung cancer, pancreatic ductal adenocarcinoma, melanoma, and castration-resistant prostate cancer. The trial is especially targeted at cancers with specific genetic mutations, such as BRAF, CRAF, RAS, and NF1 mutations, which affect the MAPK pathway that regulates cell growth and division.

Table of Contents

What is DCC-3084?

DCC-3084 is a new investigational medication being studied for the treatment of advanced cancers that are driven by specific genetic changes in what’s called the MAPK pathway[1]. The MAPK (Mitogen-Activated Protein Kinase) pathway is a chain of proteins in your cells that communicates signals from the cell surface to the DNA in the cell nucleus. When this pathway has certain mutations or abnormalities, it can lead to uncontrolled cell growth, which is a hallmark of cancer.

This medication is currently being tested in clinical trials to determine its safety and effectiveness. It can be given alone (called monotherapy) or in combination with other cancer treatments[1].

How DCC-3084 Works

While the exact mechanism isn’t fully detailed in the available information, DCC-3084 appears to target the MAPK pathway, which is involved in cell growth and division. Many cancers have mutations in this pathway, particularly in genes called RAF (including BRAF and CRAF), RAS, and NF1[1].

By targeting this pathway, DCC-3084 may help to slow or stop the growth of cancer cells that depend on these genetic mutations to survive and spread. This targeted approach is part of a growing trend in cancer treatment called precision medicine, where treatments are designed to address specific genetic changes in a person’s cancer.

What Conditions Does DCC-3084 Treat?

DCC-3084 is being studied for several types of advanced cancers, particularly those with specific genetic mutations. These include[1]:

  • Advanced solid tumors – These are cancers that form solid masses and have spread beyond their original location
  • Non-small cell lung cancer – The most common type of lung cancer
  • Pancreatic ductal adenocarcinoma – The most common type of pancreatic cancer
  • Melanoma – A serious type of skin cancer
  • Castration-resistant prostate cancer (CRPC) – An advanced form of prostate cancer that continues to grow despite treatments that lower testosterone

Specifically, DCC-3084 targets cancers with mutations in the following genes[1]:

  • BRAF gene mutations – Common in melanoma and some other cancers
  • CRAF gene mutations – Another type of RAF mutation found in various cancers
  • RAS mutations – Common in pancreatic cancer and other cancers
  • NF1 mutations – Can occur in various cancer types

Current Clinical Trial Information

DCC-3084 is currently being studied in a multicenter, Phase 1/2 clinical trial. The study is organized as follows[1]:

  • It’s designed as a “master protocol” with different modules for different cancer types
  • Currently, Module A is enrolling participants with advanced/metastatic solid tumors
  • Additional modules exploring other cancers may be added later

Each module is conducted in two parts[1]:

  1. Part 1 (Dose Escalation) – This phase is designed to find the safest and most effective dose of the medication
  2. Part 2 (Dose Expansion) – This phase further tests the selected dose in more patients

How DCC-3084 is Administered

DCC-3084 is administered orally, which means it’s taken by mouth as a pill or capsule[1]. This is more convenient than some cancer treatments that require intravenous (IV) administration in a clinic or hospital setting. The specific dosing schedule and instructions would be provided to participants in the clinical trial.

Expected Outcomes and Measurements

The clinical trial is measuring several important outcomes to determine if DCC-3084 is safe and effective[1]:

Primary Outcomes:

  • Safety – In Part 1, researchers are looking at the number of participants who experience Dose-limiting Toxicities (DLTs), which are serious side effects that might limit the use of the drug
  • Effectiveness – In Part 2, they’re measuring the Objective Response Rate (ORR), which is the percentage of participants whose cancer shrinks or disappears after treatment

Secondary Outcomes:

  • Objective Response Rate in Part 1 participants
  • Progression-Free Survival (PFS) – The time from the start of treatment until the cancer grows or spreads, or the patient dies
  • Overall Survival (OS) – The time from the start of treatment until death from any cause
  • Pharmacokinetics – How the drug moves through the body, including measurements like the maximum concentration of the drug in the blood (Cmax)

These measurements will help determine whether DCC-3084 should move forward in the development process and potentially become available as a treatment option for patients with these types of cancers[1].

Study Aspect Details
Drug Name DCC-3084
Administration Method Oral
Study Phase Phase 1/2
Study Design Multicenter, multi-cohort, open-label with dose escalation and expansion phases
Target Condition Advanced malignancies driven by the MAPK pathway
Specific Cancer Types Advanced solid tumors, non-small cell lung cancer, pancreatic ductal adenocarcinoma, melanoma, castration-resistant prostate cancer
Genetic Mutations of Interest BRAF, CRAF, RAS, NF1
Primary Outcomes Dose-limiting toxicities (Part 1), Objective response rate (Part 2)
Secondary Outcomes Objective response rate (Part 1), progression-free survival, overall survival, pharmacokinetics
Treatment Approach DCC-3084 as monotherapy and in combination with other antitumor agents
Current Status Module A enrolling participants with advanced/metastatic solid tumors; additional modules may be added

FAQ

  • What is DCC-3084 and what types of cancer is it being tested for? DCC-3084 is an investigational drug that is taken orally. It is being tested for advanced cancers driven by the MAPK pathway, including advanced solid tumors, non-small cell lung cancer, pancreatic ductal adenocarcinoma, melanoma, and castration-resistant prostate cancer. The trial is particularly interested in cancers with specific genetic mutations such as BRAF, CRAF, RAS, and NF1 mutations.
  • How is the clinical trial structured? The trial is structured as a multicenter, Phase 1/2 clinical trial with multiple modules. Currently, Module A is enrolling participants with advanced or metastatic solid tumors. Each module has two parts: Part 1 (Dose Escalation) to determine the appropriate dose and Part 2 (Dose Expansion) to further evaluate the drug's effectiveness at the established dose. Additional modules exploring other cancer types may be added later.
  • What are the main goals of this clinical trial? The main goals of the trial are to assess the safety of DCC-3084 by monitoring dose-limiting toxicities in Part 1, and to measure how effective the drug is by evaluating the objective response rate (percentage of patients whose cancer shrinks or disappears) in Part 2. The trial also aims to assess progression-free survival (time until the cancer worsens), overall survival, and how the drug behaves in the body (pharmacokinetics).
  • How is DCC-3084 administered to patients? DCC-3084 is administered orally, which means patients take it by mouth. The trial is studying the drug both as a monotherapy (used alone) and in combination with other cancer treatments. The specific dosing schedule and amounts are being determined during the trial's Dose Escalation phase.
  • What is the MAPK pathway and why is it important in this study? The MAPK (Mitogen-Activated Protein Kinase) pathway is a chain of proteins in cells that communicates signals from a receptor on the cell's surface to the DNA in the cell's nucleus. This pathway plays a crucial role in regulating cell growth, division, and survival. In many cancers, mutations in genes like BRAF, CRAF, RAS, and NF1 can cause the MAPK pathway to become overactive, leading to uncontrolled cell growth and cancer. DCC-3084 is designed to target cancers driven by abnormalities in this pathway.

Ongoing Clinical Trials on DCC-3084

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

    Not recruiting

    1 1
    Investigated drugs:
    France Germany Spain

Glossary

  • MAPK Pathway: The Mitogen-Activated Protein Kinase pathway is a chain of proteins in cells that communicates signals for cell growth and division. When this pathway has abnormalities, it can lead to uncontrolled cell growth and cancer.
  • Advanced Malignancies: Cancers that have grown beyond their original location and may have spread to other parts of the body (metastasized).
  • Monotherapy: Treatment using a single drug, rather than a combination of drugs.
  • Dose Escalation: A phase in clinical trials where researchers start with a low dose of a drug and gradually increase it to determine the safest and most effective dose.
  • Dose Expansion: A phase in clinical trials where more patients receive the dose determined in the dose escalation phase to further evaluate safety and effectiveness.
  • Dose-limiting Toxicities (DLTs): Side effects that are severe enough to prevent increasing the dose of a drug in a clinical trial.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks (partial response) or disappears completely (complete response) after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Cmax: The maximum concentration of a drug in the blood after it's been administered.
  • BRAF Gene Mutation: A change in the BRAF gene that can lead to abnormal cell growth and cancer. It's commonly found in melanoma and some other cancer types.
  • CRAF Gene Mutation: A change in the CRAF gene (also known as RAF1) that can contribute to cancer development by affecting the MAPK pathway.
  • RAS Mutation: Changes in RAS genes (KRAS, NRAS, HRAS) that can lead to constant activation of growth signaling pathways and cancer development.
  • NF1 Mutation: A change in the NF1 gene that can lead to abnormal cell growth and increased cancer risk by affecting the regulation of the MAPK pathway.
  • Non-Small Cell Lung Cancer: The most common type of lung cancer, making up about 85% of all lung cancer cases.
  • Pancreatic Ductal Adenocarcinoma: The most common type of pancreatic cancer that forms in the ducts that carry digestive enzymes.
  • Castration-Resistant Prostate Cancer (CRPC): Prostate cancer that continues to grow despite treatments that reduce testosterone levels, which normally fuel prostate cancer growth.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Multicenter Trial: A clinical study conducted at more than one medical or research institution.

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