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A Study of MK-1084 Alone and Combined with Cetuximab for People with Advanced Solid Tumors that Have a KRAS G12C Gene Change

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study involves people with advanced solid tumors, which are cancers that have spread or cannot be removed by surgery. The study focuses on tumors that have a specific change in a gene called KRAS G12C mutation. This change in the gene can affect how the cancer grows. The study will test a medication called MK-1084, which will be given either alone or together with another medication called cetuximab. The purpose of the study is to see how well these treatments work in shrinking the tumors and to check how safe they are for people taking them.

During the study, people will receive MK-1084 as tablets. Some people will also receive cetuximab, which is given through a vein. The study will compare how well MK-1084 works by itself compared to when it is given together with cetuximab. The study will measure how many tumors respond to the treatment and whether they get smaller. It will also track how long the treatment keeps working and how long people live. Throughout the study, doctors will carefully watch for any side effects or unwanted reactions to the medications.

The study will look at different types of solid tumors that have the KRAS G12C mutation, but it will not include colorectal cancer. People joining the study will have already tried standard treatments for their cancer that did not work or stopped working. The study will continue for several years to gather information about how well the treatments work over time and to ensure the safety of people taking part in the research.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    Upon joining the study, you will be assigned to one of two treatment groups.

    The first group will receive MK-1084 alone as a single treatment.

    The second group will receive MK-1084 in combination with cetuximab.

  2. Step 2

    Treatment with MK-1084

    You will receive MK-1084, which is provided as a tablet that you take by mouth.

    The medication comes in either a film-coated tablet form or a standard tablet form.

    The specific dosage, frequency, and duration of treatment will be determined by the study protocol, but these details are not specified in the available information.

  3. Step 3

    Treatment with cetuximab (if assigned to combination group)

    If you are assigned to the combination treatment group, you will also receive cetuximab.

    Cetuximab is given through an intravenous infusion, which means it is delivered directly into a vein over a period of time.

    The specific dosage, frequency, and duration of cetuximab treatment are not provided in the available information.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your tumor response will be assessed using RECIST 1.1 criteria, which is a standardized method for measuring whether tumors shrink, stay the same, or grow.

    These assessments will be performed by an independent review committee to ensure objectivity.

    Your overall health and any side effects you experience will be monitored regularly.

  5. Step 5

    Safety monitoring

    The study will track any adverse events, which are unwanted or harmful effects that may occur during treatment.

    If you experience side effects that are too severe, the treatment may be stopped or adjusted.

    Your safety and tolerability of the medication will be continuously evaluated throughout the study.

  6. Step 6

    Long-term follow-up

    The study will monitor your progression-free survival, which measures how long you live without the cancer getting worse.

    The study will also track overall survival, which is the length of time you remain alive after starting treatment.

    If your tumor responds to treatment, the duration of response will be measured to see how long the benefit lasts.

    The study is expected to continue until February 2032, though your individual participation length may vary.

Who can join the trial?

6 criteria

  • You must have a locally advanced unresectable cancer, which means the cancer has grown in the area where it started and cannot be removed by surgery, or metastatic cancer, which means the cancer has spread to other parts of the body
  • Your cancer must be a solid tumor malignancy, which is a type of cancer that forms a mass or lump, but it cannot be colorectal cancer, which is cancer of the colon or rectum
  • Your cancer must have gotten worse during or after receiving standard treatment that is normally used for your type of cancer
  • Your tumor must have a specific change in a gene called KRAS G12C mutation, which is a particular genetic alteration that can be found through laboratory testing of your tumor tissue
  • You must be an adult, which means you are at least 18 years old
  • Both men and women can participate in this study

Who cannot join the trial?

8 criteria

  • The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document.
  • Generally, clinical trials have exclusion criteria to ensure patient safety and reliable study results.
  • Common reasons patients may not be able to join cancer studies include having other serious medical conditions, taking certain medications that could interfere with the study treatment, or having received specific types of cancer treatment recently.
  • Pregnant or breastfeeding women (women who are nursing a baby) are typically not allowed to participate in cancer treatment studies due to potential risks to the baby.
  • Patients with poor overall health or whose body organs (such as liver, kidneys, or heart) are not working well enough may not be eligible.
  • People who have had allergic reactions (bad reactions where the body's defense system overreacts) to similar medications in the past may be excluded.
  • Patients with active infections or diseases affecting the immune system (the body's natural defense against illness) may not qualify.
  • Those who have participated in another clinical trial very recently may need to wait before joining this study.
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Investigated drugs

  • MK-1084

    is an investigational medication being studied in this trial. It is given to patients with advanced solid tumors that have a specific genetic change called KRAS G12C mutation. This medication can be taken alone or together with another medicine to see how well it works against cancer.

  • Cetuximab

    is a medication that is used to treat certain types of cancer. In this trial, it is being combined with MK-1084 to test whether the combination works better than MK-1084 alone. Cetuximab works by blocking signals that help cancer cells grow.

What is already known about the treatment

  • MK-1084

    MK-1084 is an experimental cancer medication currently being studied in clinical trials for treating various types of advanced solid tumors that have a specific genetic mutation called KRAS G12C. This drug is being tested both alone and in combination with another cancer medication called cetuximab to see how well it works at shrinking tumors and how safe it is for patients. The medication works by targeting and blocking the abnormal KRAS G12C protein, which is a molecular switch that, when mutated, causes cancer cells to grow and multiply uncontrollably. It belongs to a class of drugs called KRAS G12C inhibitors, which are designed to specifically attack cancer cells with this particular genetic change while potentially sparing normal healthy cells.

  • Cetuximab

    Cetuximab is an approved cancer medication that is administered through an intravenous infusion directly into the bloodstream, and in this clinical trial, it is being studied in combination with MK-1084 for patients with KRAS G12C-mutated tumors. This medication is already established in medical practice for treating certain types of cancers, particularly colorectal cancer and head and neck cancers. Cetuximab works by attaching to a protein called EGFR (epidermal growth factor receptor) on the surface of cancer cells, blocking signals that tell the cancer cells to grow and divide. It is classified as a monoclonal antibody and targeted therapy, which means it is designed to precisely identify and attack specific features of cancer cells.

Investigated diseases

Malignant Neoplasm with KRAS G12C Mutation – This is a type of cancer that contains a specific genetic change in the KRAS gene at position G12C. The KRAS gene normally helps control cell growth, but when this particular mutation occurs, cells can grow and divide uncontrollably. This genetic alteration is found in various types of cancers, including lung cancer and colorectal cancer. The mutation causes the KRAS protein to remain active continuously, sending constant signals for cells to multiply. As the disease progresses, the abnormal cells form tumors that can grow larger and potentially spread to other parts of the body. This specific mutation affects how cancer cells respond to signals that normally regulate their growth and division.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521737-91-00Protocol codeMK-1084-014Estimated enrolment171 patientsSponsorMerck Sharp & Dohme LLC

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