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Study of Sotorasib Alone and Combined with Pembrolizumab in Adult Patients with Advanced Solid Tumors Having KRAS p.

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 focuses on patients with advanced solid tumors and non-small cell lung cancer (NSCLC) that have a specific genetic change called KRAS p.G12C mutation. The main purpose is to test a new medication called sotorasib (also known as AMG 510), which is given as a tablet taken by mouth. The study will look at how safe the medication is and how well it works in treating these types of cancer.

The research involves different groups of patients who will receive different treatments. Some patients will take sotorasib alone, while others will receive it in combination with another cancer medication called pembrolizumab. The study includes patients with various types of solid tumors, including colorectal cancer. Different doses of the medication will be tested, including once-daily and twice-daily dosing schedules.

Throughout the study, doctors will monitor patients' responses to treatment using various medical tests including computed tomography (CT) and magnetic resonance imaging (MRI) scans. They will track how the tumors respond to treatment and watch for any side effects. The study will also look at how the medication moves through the body and how it affects patients' quality of life and cancer-related symptoms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility verification

    Your eligibility for the study will be confirmed based on two main criteria:

    - Age requirement: you must be 18 years or older

    - Medical condition: you must have a documented locally-advanced or metastatic cancer with confirmed KRAS p.G12C mutation

  2. Step 2

    Treatment administration

    You will receive sotorasib (AMG 510) treatment in one of several possible ways:

    - Once daily dosing

    - Twice daily dosing

    - Once daily dosing with food

    Some participants may receive sotorasib in combination with another medication called pembrolizumab, depending on their specific treatment group

  3. Step 3

    Monitoring and assessments

    Throughout the study, you will undergo regular health checks including:

    - Physical examinations

    - Vital signs measurements

    - Heart monitoring (ECG)

    - Laboratory tests

    - Imaging scans (CT or MRI) to assess your response to treatment

  4. Step 4

    Response evaluation

    Your response to treatment will be evaluated through:

    - Regular imaging scans at least every 4 weeks after initial response

    - Assessment of any changes in tumor size

    - Monitoring of any side effects

    - Evaluation of your overall health status

  5. Step 5

    Study duration

    The study is scheduled to run from August 2018 to May 2027

    Your individual participation duration will depend on your response to treatment and overall health status

Who can join the trial?

5 criteria

  • Must be 18 years or older
  • Must have a confirmed diagnosis of advanced or metastatic cancer (cancer that has spread beyond its original location)
  • Must have a specific genetic mutation called KRAS p.G12C in their tumor, which must be confirmed through laboratory testing
  • Both men and women can participate
  • Must have locally advanced cancer (cancer that has grown into nearby tissues) or metastatic cancer (cancer that has spread to other parts of the body)

Who cannot join the trial?

15 criteria

  • History of treatment with any KRAS G12C inhibitor (medications targeting specific genetic mutation)
  • Current treatment with medications that strongly affect liver enzymes
  • Active brain metastases (cancer that has spread to the brain) that are not stable
  • History of other cancers within the past 5 years, except for successfully treated skin cancer or early-stage cancer
  • Significant heart problems, including:
    • Heart attack within past 6 months
    • Unstable heart rhythm problems
    • Uncontrolled high blood pressure
    • Active infections requiring treatment
    • Known HIV infection (human immunodeficiency virus)
    • Active hepatitis B or C infection (liver infections)
    • Major surgery within 28 days before starting the study
    • Pregnancy or breastfeeding
    • Any medical condition that could interfere with the study treatment or affect patient safety
    • Unable to swallow oral medications
    • Known allergies to the study medication or its components
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Investigated drugs

  • Sotorasib

    (also known as AMG 510) is a medication designed to target tumors with a specific genetic mutation called KRAS p.G12C. It works by blocking the abnormal protein that causes cancer cells to grow and spread. This medication is being studied for treating various types of advanced solid tumors, particularly non-small cell lung cancer and colorectal cancer.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. In this trial, it is being studied in combination with Sotorasib for treating advanced non-small cell lung cancer. Pembrolizumab works by blocking a protein that prevents the immune system from attacking cancer cells.

What is already known about the treatment

  • Sotorasib (AMG 510)

    An oral medication administered once or twice daily that specifically targets KRAS p.G12C mutations in advanced solid tumors. This novel therapeutic agent is currently being investigated in clinical trials for treating various types of advanced cancers, particularly non-small cell lung cancer (NSCLC) and colorectal cancer. Sotorasib works by selectively inhibiting the KRAS G12C protein, which is responsible for tumor cell growth and survival, making it the first drug of its kind to specifically target this mutation. It belongs to the class of targeted cancer therapies known as KRAS inhibitors, representing a significant advancement in precision medicine for cancer treatment.

  • Pembrolizumab

    An immunotherapy medication administered intravenously that is being studied in combination with Sotorasib for treating advanced non-small cell lung cancer (NSCLC). This established cancer drug works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. It belongs to the class of immune checkpoint inhibitors and has already proven effective in various cancer types, with its combination with Sotorasib being investigated to potentially enhance treatment outcomes for patients with KRAS p.G12C mutant NSCLC.

Investigated diseases

  • Non-small Cell Lung Cancer (NSCLC)

    A type of lung cancer that begins in the large cells of the lungs, including squamous cells, adenocarcinomas, and large cell carcinomas. The disease develops when lung cells begin to grow uncontrollably and form tumors. It typically develops slowly and may spread to other parts of the body through the blood or lymph system.

  • Colorectal Cancer (CRC)

    A cancer that starts in either the colon or the rectum, typically developing from small growths called polyps. The disease begins when healthy cells in the lining of the colon or rectum develop mutations and grow abnormally. It can spread through the wall of the colon or rectum and affect nearby structures.

  • KRAS p.G12C Mutant Advanced Solid Tumors

    A specific type of cancer characterized by a mutation in the KRAS gene at position G12C, which can occur in various solid organs. This mutation causes abnormal cell growth and division. These tumors can develop in different parts of the body and are characterized by uncontrolled cell growth driven by this specific genetic change.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-511798-31-00Protocol code20170543Estimated enrolment932 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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