Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors

This research study is looking into a new treatment called TNG908 for adults with advanced or spreading cancers that have a particular genetic change, known as MTAP-deleted. This includes different types of solid tumours such as lung cancer, mesothelioma, sarcoma, and pancreatic cancer, as well as a type of brain tumour called glioblastoma. The main goals are to find out how safe the drug is, what side effects it might cause, and to determine the best dose to use. Researchers will also be checking if TNG908 can help to stop the cancer from growing or even shrink the tumours. This is an early-stage study, meaning it's one of the first times this drug is being used in people.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Tango Therapeutics Inc.

Enrolment target

Start

03 Oct 2024

What is this study about?

This study is investigating a new medication called TNG908. It's designed for people who have advanced or spreading solid tumours, or a specific type of brain tumour, that all share a particular genetic change. This change is called 'MTAP-deleted'. This genetic change means the cancer cells might be more vulnerable to certain treatments, and TNG908 is designed to target this vulnerability.

The main aim of the first part of the study (Phase 1) is to figure out if TNG908 is safe and to find the highest dose that can be given without causing too many serious side effects. Once a safe dose is identified, the second part of the study (Phase 2) will broaden the number of people taking part. This phase will focus on seeing how well the drug works against various specific types of MTAP-deleted cancers. Researchers will be looking to see if the tumours shrink or stop growing, how long the positive effects last, and the overall health and well-being of the participants.

This is an "open-label" study, which means both you and your study doctor will know that you are receiving the study drug TNG908. It's important to remember that this is a new drug, and while researchers hope it will be helpful, its full effects are still being understood.

Key takeaways

This study is testing a new drug called TNG908 for specific advanced cancers.
It's for cancers with a genetic change called 'MTAP-deleted'.
The study aims to check the drug's safety, find the best dose, and see if it helps shrink tumours.
It's an early-stage study, so the drug's full effects are still being investigated.
Participation involves regular clinic visits for tests and monitoring.
You can leave the study at any time if you wish.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women. A crucial requirement is that your cancer must have a specific genetic change, which doctors call 'MTAP-deleted'. This will need to be confirmed by tests.

Your cancer must be advanced, meaning it has either spread to other parts of your body (metastatic) or is locally advanced, where it has grown significantly in its original location. The study is looking for people with different types of cancer, including certain lung cancers, mesothelioma, sarcomas, pancreatic cancers, and specific brain tumours (astrocytoma or glioblastoma).

If you have received treatment for your brain tumour before and it has come back or is no longer responding to treatment, you might also be eligible. Your study doctor will review other health factors to ensure that taking part in the study is the right and safest choice for you.

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?
Has your doctor confirmed your cancer has the 'MTAP-deleted' genetic change?
Is your cancer advanced or has it spread?
Are you able to attend regular clinic appointments for tests?
Have you discussed this study with your current doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new drug, TNG908. The study aims to look closely at your health during this time. This will involve regular visits to the study clinic where you will have blood tests, checks of your vital signs (like blood pressure and heart rate), and scans to see how your cancer is responding to the treatment. You might also have other tests to understand how the drug works in your body.

The initial part of the study (Phase 1) focuses on finding the right dose and understanding any side effects within the first 28 days of starting the drug. Throughout the study, you'll be closely monitored for any changes in your health or any side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will have ongoing follow-up. You will also be given a general medication called Midazolam at certain points, likely to help with any procedures or symptoms as needed.

Potential risks and benefits

Participating in an early-stage study like this means there's a chance you could benefit from a new treatment if TNG908 proves effective for your type of cancer. However, as it's a new drug, there are also potential risks of side effects that are not yet fully known. These will be carefully monitored by the study team, and they 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 medical care.

Locations (1)

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

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Unverified
France

Common questions

What is MTAP-deleted cancer?

It's a specific genetic change found in some cancer cells. TNG908 is designed to target cancers with this particular change.

What does 'Phase 1/2' mean?

This means it's an early study. Phase 1 focuses on safety and finding the right dose, while Phase 2 looks at how well the drug works in more people.

Will I definitely get the TNG908 drug?

Yes, in this specific study, everyone who participates will receive the TNG908 drug.

What kind of side effects might I experience?

As this is an early study, all potential side effects are being carefully monitored. Your study doctor will discuss known and potential side effects with you.

How long will I be in the study?

The length of your participation will depend on your response to the treatment and the overall study plan. You will be monitored closely throughout.