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Dcc-3116

DCC-3116 is an innovative drug currently being studied in clinical trials for its potential in treating various advanced cancers. These trials aim to evaluate the safety and effectiveness of DCC-3116 when used alone or in combination with other anticancer therapies. The studies focus on patients with solid tumors, particularly those with mutations in the RAS/MAPK pathway, and explore different dosing strategies to determine the optimal treatment approach.

Table of Contents

What is DCC-3116?

DCC-3116 is a new drug being developed to treat various types of advanced or metastatic cancers. It is currently undergoing clinical trials to evaluate its safety and effectiveness. DCC-3116 is administered as an oral tablet, which means it can be taken by mouth[1][2].

What Conditions Does DCC-3116 Target?

DCC-3116 is being studied for the treatment of several types of cancer, including:

  • Advanced solid tumors: These are cancers that form solid masses in the body and have spread beyond their original location.
  • Metastatic solid tumors: These are cancers that have spread from their original site to other parts of the body.
  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that accounts for most lung cancer cases.
  • Gastrointestinal Stromal Tumor (GIST): A rare type of cancer that occurs in the digestive tract, most commonly in the stomach or small intestine[1][2].

How Does DCC-3116 Work?

DCC-3116 is designed to target cancers with specific genetic mutations in the RAS/MAPK pathway. This pathway is a chain of proteins in the cell that communicates a signal from a receptor on the surface of the cell to the DNA in the nucleus. When this pathway is overactive due to mutations, it can lead to cancer growth. DCC-3116 aims to interrupt this process and potentially slow down or stop cancer progression[2].

Current Clinical Trials

DCC-3116 is currently being evaluated in two main clinical trials:

  1. Phase 1/2 Study in RAS/MAPK Pathway Mutant Solid Tumors: This study is testing DCC-3116 alone and in combination with other cancer drugs in patients with advanced or metastatic solid tumors that have mutations in the RAS/MAPK pathway[2].
  2. Phase 1/2 Study in Combination with Anticancer Therapies: This study is evaluating DCC-3116 in combination with other anticancer therapies in patients with advanced cancers[1].

Combination Therapies

Researchers are studying DCC-3116 in combination with several other cancer drugs to potentially enhance its effectiveness. These combinations include:

  • Ripretinib (also known as QINLOCK or DCC-2618): Used for treating gastrointestinal stromal tumors (GIST)[1].
  • Trametinib: A drug used to treat certain types of cancer with specific genetic mutations[2].
  • Binimetinib: Another targeted therapy used in cancer treatment[2].
  • Sotorasib: A drug specifically designed for cancers with a KRAS G12C mutation, particularly in non-small cell lung cancer[2].

Safety and Efficacy Measures

The clinical trials are evaluating several important aspects of DCC-3116:

  • Safety: Researchers are closely monitoring for any side effects or adverse events related to the drug[1][2].
  • Efficacy: The trials are measuring how well the drug works using various metrics:
    • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
    • Duration of Response (DoR): How long the cancer remains controlled after it responds to treatment.
    • Disease Control Rate (DCR): The percentage of patients whose cancer shrinks or remains stable.
    • Progression-Free Survival (PFS): How long patients live without their cancer getting worse.
    • Overall Survival (OS): How long patients live after starting treatment[1][2].

Future Prospects

While DCC-3116 is still in the early stages of clinical development, it shows promise for treating various advanced cancers, particularly those with specific genetic mutations. The ongoing trials will provide crucial information about its safety and effectiveness, both as a single agent and in combination with other cancer therapies. If successful, DCC-3116 could potentially offer new treatment options for patients with hard-to-treat cancers[1][2].

Aspect Details
Drug Name DCC-3116
Administration Oral tablet
Cancer Types Studied Advanced solid tumors, metastatic solid tumors, GIST, NSCLC
Study Phases Phase 1/2
Study Design Dose escalation and expansion phases
Combination Therapies Ripretinib, trametinib, binimetinib, sotorasib
Primary Outcomes Safety, maximum tolerated dose, recommended Phase 2 dose, objective response rate
Secondary Outcomes Duration of response, disease control rate, time to response, progression-free survival, pharmacokinetics
Target Patient Population Patients with RAS/MAPK pathway mutations
Study Duration Approximately 24-48 months

FAQ

  • What is DCC-3116 and what types of cancer is it being studied for? DCC-3116 is an experimental drug being studied for the treatment of advanced or metastatic solid tumors. It is being tested in patients with various types of cancer, including gastrointestinal stromal tumors (GIST) and non-small cell lung cancer (NSCLC), especially those with specific genetic mutations like RAS/MAPK pathway mutations.
  • How is DCC-3116 administered in these clinical trials? DCC-3116 is administered as an oral tablet. In the trials, it is given either as a single agent (monotherapy) or in combination with other anticancer drugs. The dosing schedule varies, but it is typically given twice daily in 28-day cycles.
  • What are the main goals of these clinical trials involving DCC-3116? The main goals of these trials are to determine the safety of DCC-3116, identify the best dose for future studies (called the recommended Phase 2 dose), and evaluate its effectiveness in treating cancer. The trials also aim to understand how the body processes the drug and how it interacts with other cancer treatments.
  • What are some of the other drugs being tested in combination with DCC-3116? DCC-3116 is being tested in combination with several other anticancer drugs, including ripretinib (for GIST), trametinib, binimetinib, and sotorasib (for solid tumors with specific mutations). These combinations are being explored to potentially enhance the effectiveness of treatment.
  • How do researchers measure the effectiveness of DCC-3116 in these trials? Researchers measure the effectiveness of DCC-3116 through various outcomes. These include the objective response rate (the proportion of patients whose tumors shrink), duration of response (how long the response lasts), disease control rate (the proportion of patients whose disease doesn't worsen), and progression-free survival (time until the cancer grows or spreads). They also monitor overall survival and the time it takes for patients to respond to the treatment.

Ongoing Clinical Trials on Dcc-3116

  • Study of DCC-3116 and ripretinib combination therapy in patients with advanced gastrointestinal stromal tumor (GIST)

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Italy The Netherlands +2

  • Study of DCC-3116 with Sotorasib, Binimetinib, and Trametinib for Patients with Advanced or Metastatic Solid Tumors with RAS/MAPK Pathway Mutations

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

Glossary

  • RAS/MAPK pathway: A chain of proteins in cells that communicates a signal from a receptor on the surface of the cell to the DNA in the nucleus of the cell. This pathway is important in cancer research because when it's overactive, it can lead to cancer growth.
  • Solid tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer) or malignant (cancer). Examples include sarcomas, carcinomas, and lymphomas.
  • Metastatic: Cancer that has spread from the place where it first started to another place in the body. This is also known as stage IV cancer.
  • Dose-limiting toxicity (DLT): Side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined in early clinical trials to be appropriate for testing in larger groups of patients in later phase trials.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial Response (PR): A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
  • Stable Disease (SD): Cancer that is neither decreasing nor increasing in extent or severity.
  • 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.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. This includes measures like Cmax, Tmax, Cmin, and AUC.

References