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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Quironsalud Barcelona	Barcelona	Spain
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Aovutnqsfw Pplnthvb Hkdwcojy Dm Mwwgreokb	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2023
Italy	Not recruiting	01.09.2023
Spain	Not recruiting	01.09.2023

Trial locations

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.

Investigated diseases:

Neoplasm

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 ID:

2022-503060-33-00

Protocol code:

NGM707-IO-101

NCT ID:

NCT04913337

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

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