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Study of NGM707 and Pembrolizumab for Patients with Advanced or Metastatic Solid Tumors

Verified siteInvestigationalNo placebo
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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 treatments for advanced or metastatic solid tumors, which are types of cancer that have spread to other parts of the body. The study involves two treatments: NGM707, a new investigational drug, and pembrolizumab, also known as Keytruda, which is a medication already used in cancer treatment. NGM707 is being tested both on its own and in combination with pembrolizumab to see how effective and safe it is for patients with these types of cancers.

The purpose of the study is to evaluate the antitumor activity and safety of NGM707 when used alone and in combination with pembrolizumab. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, with regular visits to monitor the effects of the treatment and ensure the safety of the participants. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, doctors will closely observe how the tumors respond to the treatments and will also monitor for any side effects. The study aims to provide valuable information on whether NGM707, alone or with pembrolizumab, can be a beneficial treatment option for people with advanced or metastatic solid tumors. This research is important for developing new therapies that could improve outcomes for patients with these challenging types of cancer.

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

    Joining the study

    Upon joining the study, you will be required to provide a tumor biopsy. This can be an archival sample taken within the last year or a fresh biopsy if the archival sample is not available.

    You will need to agree to use appropriate contraception methods if you are of childbearing potential, or if you are a male participant with a female partner of childbearing potential.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the study's eligibility criteria. This includes confirming your diagnosis of advanced or metastatic solid tumor malignancies and ensuring you are not eligible for local therapy with curative intent.

    Your general health will be evaluated, including bone marrow, liver, and kidney function, to ensure they meet the study's requirements.

  3. Step 3

    Treatment phase

    You will receive the study medications, NGM707 and pembrolizumab, through an intravenous infusion. The specific dosage and frequency will be determined by the study protocol and your individual health needs.

    The treatment will continue for a specified duration, which will be communicated to you by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular visits will be scheduled to monitor your health and the effects of the treatment. This includes laboratory tests and assessments of any side effects.

    You will be required to report any changes in your health or any side effects you experience during the study.

  5. Step 5

    End of study

    At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment on your condition.

    You will be informed about the next steps and any follow-up care that may be necessary.

Who can join the trial?

14 criteria

  • Must be a male or female aged 18 years or older.
  • Must understand and be willing to sign an informed consent form (ICF) and follow the study schedule, including visits, treatments, and tests.
  • Women of childbearing potential must agree to use two methods of birth control from the start of the study until four months after the last dose of the study drug. Acceptable methods include surgical sterilization, an intrauterine device (IUD), or hormonal contraception with a barrier method like a condom.
  • Men who are sexually active with a female partner of childbearing potential must agree to use a condom with a spermicidal product from the start of the study until four months after the last dose of the study drug. Their female partner should also use an IUD or hormonal contraception. This requirement does not apply to men who had a vasectomy more than six months before joining the study.
  • Must provide a tumor biopsy sample taken within one year before joining the study. If not available, a new biopsy is acceptable.
  • Must have at least one measurable tumor according to specific medical criteria.
  • Must have a confirmed diagnosis of advanced or metastatic solid tumor cancer.
  • Must not be eligible for local treatments like surgery or radiation with the intent to cure.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate bone marrow function, including specific levels of white blood cells, platelets, and hemoglobin.
  • Must have adequate liver function, including specific levels of bilirubin, AST, and ALT, which are liver enzymes.
  • Must have adequate kidney function, measured by serum creatinine levels or creatinine clearance rate.
  • Must have specific blood clotting times unless taking blood-thinning medication.
  • Must have recovered from any side effects of previous treatments to a mild level, except for effects that are not considered a safety risk by the study doctor.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to safely participate in the study due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have certain infections or diseases that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend required visits.
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Investigated drugs

  • NGM707

    is an experimental medication being studied for its potential to treat advanced or metastatic solid tumors. It is designed to help the body's immune system recognize and attack cancer cells more effectively. In this clinical trial, researchers are testing NGM707 to see how well it works on its own and when used together with another medication called pembrolizumab.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better identify and destroy these cells. Pembrolizumab is already used to treat various types of cancer, and in this trial, it is being combined with NGM707 to see if the combination is more effective than using either treatment alone.

What is already known about the treatment

  • NGM707

    NGM707 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating advanced or metastatic solid tumor malignancies. The main therapeutic indication for NGM707 is to help the immune system fight cancer by targeting specific proteins that may suppress immune responses. At the molecular level, NGM707 works by blocking these proteins, potentially allowing the immune system to better recognize and attack cancer cells. It is classified as an immunotherapy agent, which is a type of treatment that uses the body's own immune system to combat diseases like cancer.

  • Pembrolizumab

    Pembrolizumab is also administered as an intravenous infusion and is a well-established medication in the field of oncology, particularly for treating various types of cancer. It is used in combination with NGM707 in clinical trials to enhance the immune system's ability to fight advanced or metastatic solid tumor malignancies. Pembrolizumab works by inhibiting a protein called PD-1, which can prevent the immune system from attacking cancer cells. By blocking this protein, pembrolizumab helps the immune system to better identify and destroy cancer cells. It is classified as a checkpoint inhibitor, a type of immunotherapy that helps to unleash the immune system against cancer.

Investigated diseases

Advanced or Metastatic Solid Tumor Malignancies – These are cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. The disease begins when abnormal cells grow uncontrollably, forming a mass or tumor. As the disease advances, these tumors can invade nearby tissues and organs. In metastatic cases, cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in distant organs. The progression of the disease can vary depending on the type of cancer and its location. Symptoms may include pain, fatigue, and weight loss, among others, depending on the organs affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503060-33-00Protocol codeNGM707-IO-101Estimated enrolment120 patientsSponsorNgm Biopharmaceuticals Inc.

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