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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying several types of cancer, including Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Melanoma, Metastatic Solid Tumor, Advanced Solid Tumor, and Non-Small Cell Lung Cancer. The study will explore the effects of a new treatment called DCC-3116, which will be tested both on its own and in combination with other medications that target the RAS/MAPK Pathway, a series of proteins in the cell that communicate signals from a receptor on the surface of the cell to the DNA in the nucleus of the cell. These medications include Sotorasib (also known as AMG 510), Binimetinib (also known as MEK162), and Trametinib (also known as GSK1120212B).

The purpose of this study is to evaluate how well these treatments work in patients with specific genetic mutations in their tumors. Participants will receive the study medication in the form of tablets taken by mouth. The study will be conducted in two parts. In the first part, the safety and best dose of DCC-3116 will be determined. In the second part, the effectiveness of the combination treatments will be assessed. Throughout the study, participants will be monitored for any side effects and the response of their cancer to the treatment.

The study aims to provide valuable information on the potential benefits of these treatments for patients with these types of cancer. The trial is expected to continue until 2028, with recruitment starting in early 2024. Participants will be closely followed by the study team to ensure their safety and to gather data on how the treatments affect their cancer. This research could lead to new treatment options for patients with these challenging conditions.

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 visit

    Upon joining the clinical trial, you will have an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the study. This includes providing a fresh tumor biopsy or an archival tumor tissue sample if a fresh biopsy is not possible.

    You will also have a physical examination and your medical history will be reviewed. Your performance status will be assessed to ensure it meets the required criteria.

  2. Step 2

    Treatment phase

    Once eligibility is confirmed, you will enter the treatment phase. You will receive the study medication, which may include sotorasib, binimetinib, dcc-3116, or trametinib. These medications are taken orally in the form of film-coated tablets.

    The dosage and frequency of the medication will be determined by the study protocol and your specific treatment plan. You will be informed of the exact dosage and schedule during this phase.

  3. Step 3

    Regular monitoring

    Throughout the trial, you will have regular monitoring visits. These visits are designed to assess your response to the treatment and to monitor for any side effects.

    You will undergo various tests and assessments, including imaging studies and blood tests, to evaluate the effectiveness of the treatment and to ensure your safety.

  4. Step 4

    End of treatment

    At the end of the treatment phase, you will have a final evaluation. This will include a comprehensive assessment of your health and a review of your response to the treatment.

    You will be informed about the next steps, which may include follow-up visits or additional treatments, depending on your condition and the study's findings.

Who can join the trial?

5 criteria

  • At least 18 years of age
  • Have progressed despite standard therapies, or for whom conventional therapy is not considered effective or tolerable, as judged by the Investigator
  • Must provide a fresh tumor biopsy from a primary or metastatic cancer lesion that can be biopsied with acceptable risk as determined by the Investigator during the Screening Period and an archival tumor tissue sample, if available (preferably collected after last anticancer therapy). If a fresh tumor biopsy is not possible, then an archival tumor tissue sample must be provided
  • Must have at least 1 measurable lesion according to RECIST v1.1 (a standard way to measure how well a cancer treatment works)
  • Eastern Cooperative Oncology Group (ECOG) performance status at Screening of 0 to 1 (a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities; 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work)

Who cannot join the trial?

6 criteria

  • Patients with **Pancreatic Ductal Adenocarcinoma** cannot participate.
  • Patients with **Colorectal Cancer** cannot participate.
  • Patients with **Melanoma** cannot participate.
  • Patients with a **Metastatic Solid Tumor** cannot participate. A metastatic solid tumor is a type of cancer that has spread from its original location to other parts of the body.
  • Patients with an **Advanced Solid Tumor** cannot participate. An advanced solid tumor is a cancer that has grown significantly or spread to other parts of the body.
  • Patients with **Non-Small Cell Lung Cancer** cannot participate.
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Investigated drugs

  • DCC 3116

    is an experimental medication being tested for its potential to treat advanced or metastatic solid tumors. It is being studied both on its own and in combination with other treatments. The goal is to see if it can help stop or slow down the growth of tumors that have specific genetic changes known as RAS/MAPK pathway mutations. This medication is still in the early stages of research, so its effectiveness and safety are being closely monitored.

  • RAS/MAPK Pathway Inhibitors

    are a group of medications that target a specific pathway in cells that is often involved in the growth and spread of cancer. By blocking this pathway, these inhibitors aim to prevent cancer cells from growing and dividing. In this trial, they are being used in combination with DCC 3116 to see if the combination is more effective than using either treatment alone. The study is looking to find out if this combination can improve the response rate in patients with tumors that have mutations in the RAS/MAPK pathway.

What is already known about the treatment

DCC 3116 – DCC 3116 is an investigational medication currently being studied in clinical trials for its potential to treat various types of advanced or metastatic solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer, melanoma, non-small cell lung cancer, and other solid tumors with specific genetic mutations. It is administered orally, meaning patients take it by mouth. The drug is being tested both as a standalone treatment and in combination with other medications that target the RAS/MAPK pathway, a key signaling pathway involved in cell growth and cancer development. DCC 3116 works by interfering with this pathway, potentially slowing down or stopping the growth of cancer cells. It is classified as a targeted therapy, which means it aims to specifically attack cancer cells with minimal harm to normal cells.

Investigated diseases

  • Pancreatic Ductal Adenocarcinoma

    This is a type of cancer that begins in the ducts of the pancreas. It typically grows and spreads quickly, often invading nearby organs and tissues. As it progresses, it can cause symptoms like abdominal pain, weight loss, and jaundice. The disease may spread to lymph nodes and other parts of the body. It often remains undetected until it is advanced due to its deep location in the abdomen.

  • Colorectal Cancer

    This cancer starts in the colon or rectum, parts of the large intestine. It usually begins as a growth called a polyp on the inner lining, which can become cancerous over time. As it progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The disease can eventually spread to other organs, such as the liver or lungs.

  • Melanoma

    Melanoma is a type of skin cancer that develops from melanocytes, the cells that produce pigment. It often appears as a new mole or a change in an existing mole. As it progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early stages may be asymptomatic, but advanced stages can cause symptoms like itching, bleeding, or ulceration. It is more aggressive than other types of skin cancer.

  • Metastatic Solid Tumor

    This refers to a solid tumor that has spread from its original site to other parts of the body. The progression involves the tumor cells breaking away and traveling through the bloodstream or lymphatic system. These cells can form new tumors in other organs or tissues. Symptoms vary depending on the location of the metastases. The disease can affect multiple organs, leading to a range of systemic symptoms.

  • Advanced Solid Tumor

    An advanced solid tumor is a cancer that has grown beyond its original site and may have spread to other parts of the body. It often involves significant growth and invasion into surrounding tissues. As it progresses, it can cause symptoms related to the affected organs, such as pain or dysfunction. The disease may also lead to systemic symptoms like fatigue or weight loss. It is characterized by its extensive spread and impact on the body.

  • Non-Small Cell Lung Cancer

    This is the most common type of lung cancer, accounting for a majority of cases. It typically starts in the tissues of the lungs and can grow and spread to other parts of the body. As it progresses, it may cause symptoms such as a persistent cough, chest pain, and shortness of breath. The disease can invade nearby tissues and spread to lymph nodes and distant organs. It is often diagnosed at an advanced stage due to subtle early symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-501474-19-00Protocol codeDCC-3116-01-001Estimated enrolment88 patientsSponsorDeciphera Pharmaceuticals Inc.

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