Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

This research study is about a new medicine called NGM707. It's being tested by itself and together with another drug, pembrolizumab, for people who have advanced or metastatic solid tumors. This means the cancer has spread from where it started. The main goals of the study are to find out if NGM707 is safe to use and to see how well it works. Doctors will be carefully watching for any side effects and checking if the tumors get smaller. This is an early-stage study, so it helps researchers understand more about these new treatments for serious cancers.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ngm Biopharmaceuticals Inc.

Enrolment target

Start

04 Jul 2023

Advanced or Metastatic Solid Tumor Malignancies

What is this study about?

This research study is investigating a new medication called NGM707. It's being tested in people who have solid tumors that are advanced or have spread to other parts of the body (called metastatic cancer). Doctors want to see how safe NGM707 is when given alone, and also when it's given with another anti-cancer drug called pembrolizumab. The main reasons for this study are to make sure the drugs are safe and tolerable, meaning people can take them without too many difficult side effects. The researchers will be closely monitoring participants for any side effects and how serious they are. They will also be looking to see if the treatment has a positive effect on the cancer, such as shrinking tumors or stopping their growth, using special scans and tests. This is an early-stage study, which means it's an important step in learning about new potential treatments for cancer. The results will help doctors understand more about how these drugs work and if they could be helpful for people with advanced solid tumors in the future. It’s part of a careful process to find new ways to fight cancer.

Key takeaways

Investigating a new drug (NGM707) for advanced solid tumors.
Testing NGM707 alone and with pembrolizumab.
Main goals are checking safety and if it shrinks tumors.
Participation involves regular clinic visits, blood tests, and scans.
Potential benefits (new treatment) and risks (side effects) exist.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to take part. Beyond your age and gender, there will be other important health checks to see if this study is right for you. These might include things like the type of cancer you have, how well your liver and kidneys are working, and if you've had certain treatments in the past. These checks are important to make sure the study treatments are as safe as possible for you. It's really important to discuss all your current and past health conditions, as well as any medicines you're taking, with the study doctor. They will carefully review everything to confirm if you can safely participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an advanced or metastatic solid tumor?
Are you willing to have regular clinic visits and tests?
Are you able to understand the study requirements and give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would likely have regular visits to the clinic. These visits might involve physical examinations, blood tests, and scans to check your health and how the treatment is working. You would receive the study drugs, NGM707 (either alone or with pembrolizumab), likely through an infusion into your vein. The specific schedule and number of treatments would be explained by the study team. Throughout the study, doctors and nurses will closely monitor you for any side effects. You might also be asked to complete questionnaires about how you're feeling. There will be regular follow-up appointments even after your treatment ends to keep an eye on your progress. The total duration of your participation would depend on how your body responds to the treatment, but the full study length could be several months or longer.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new and innovative treatment for your cancer that isn't widely available yet. There is a chance the treatment might help shrink your tumor or slow its growth. However, like all medicines, the study drugs come with potential risks, including side effects that can range from mild to serious. The study team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Italy
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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumors, which means the cancer has grown or spread from where it started.

What kind of treatments will I receive?

You will receive a new drug called NGM707, either by itself or together with another drug called pembrolizumab. These are usually given through an infusion.

What are the main goals of this study?

The main goals are to check if the study drugs are safe and to see if they can shrink tumors or stop them from growing.

Will I have side effects?

All medicines have potential side effects. The study team will carefully monitor you for any unwanted effects and explain what to expect.

How long will I be in the study?

The length of time you participate will depend on how your body responds, but it could be several months or longer, with regular follow-up.