Study on the Safety and Effectiveness of TNG462 for Patients with Advanced or Metastatic Solid Tumors with MTAP Deletion

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What is this study about?

This clinical trial is focused on studying a type of cancer known as MTAP-deleted advanced or metastatic solid tumors. These are cancers that have spread to other parts of the body and have a specific genetic change called MTAP deletion. The study is testing a new treatment called TNG462, which is a film-coated tablet taken by mouth. TNG462 is a small molecule designed to specifically target and inhibit a protein called PRMT5, which is involved in the growth of cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of TNG462 in patients with these specific types of tumors. The study is divided into two phases. In the first phase, researchers will determine the best dose of TNG462 to use. In the second phase, they will assess how well the treatment works in shrinking the tumors. Participants will receive TNG462 and will be monitored for any side effects and changes in their cancer.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their cancer. This will include various tests and assessments to ensure the treatment is safe and to measure its impact on the cancer. The study aims to provide valuable information on the potential benefits of TNG462 for patients with MTAP-deleted advanced or metastatic solid tumors.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to ensure you meet the study criteria.

You will be required to provide written informed consent, acknowledging your understanding of the study and your willingness to participate.

2 treatment phase 1

In the first phase of treatment, you will receive the medication TNG462 in the form of a film-coated tablet. The dosage will be determined by the study team based on safety and tolerability assessments.

This phase aims to determine the maximum tolerated dose and the recommended dose for further study. You will be monitored closely for any side effects or reactions to the medication.

3 treatment phase 2

If you continue to the second phase, the focus will be on assessing the anti-tumor activity of TNG462. The dosage will be based on findings from the first phase.

You will continue to take the medication as a film-coated tablet, and your response to the treatment will be evaluated regularly.

4 monitoring and follow-up

Throughout the study, regular monitoring will occur to assess your health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

You will be asked to report any side effects or changes in your condition. The study team will provide guidance on managing any symptoms you experience.

5 completion and evaluation

At the end of the study, a final evaluation will be conducted to assess the overall impact of the treatment on your condition.

You will receive information about the study’s findings and any potential next steps for your care.

Who Can Join the Study?

Age: You must be 18 years or older to join the study.
You need to have a performance status of 0 to 1 on the ECOG scale, which means you should be fully active or have some symptoms but still be able to carry out light work.
You must have a confirmed diagnosis of a locally advanced, metastatic, or unresectable solid tumor. This means your cancer has spread or cannot be removed by surgery.
You should have received standard therapy before, if available. This means you have tried the usual treatments for your condition.
Your tumor must have a bi-allelic (homozygous) deletion of MTAP, which means a specific genetic change, confirmed by special tests.
You need to have adequate organ function, which will be checked by local lab tests.
You must have adequate liver function, confirmed by local lab tests.
You need to have adequate kidney function, as shown by local lab tests.
If you are a woman who can have children, you must have a negative pregnancy test at the start of the study.
You must provide written informed consent, which means you agree to participate after being informed about the study details.

Who Cannot Join the Study?

Patients who do not have MTAP-deleted advanced or metastatic solid tumors cannot participate. This means the study is only for those with a specific type of tumor that has a certain genetic change.
Patients who are not within the specified age range cannot participate. The study is for adults, so children and teenagers are excluded.
Patients who are not able to give informed consent cannot participate. This means that if someone cannot understand the study and agree to take part, they cannot join.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients with other serious health conditions that might interfere with the study cannot participate. This is to make sure the study results are accurate and not affected by other illnesses.
Patients who have had another cancer treatment recently cannot participate. This is to ensure that the effects of the study treatment are not mixed with other treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Iagbbjcs Cmgfik Damthvnwdxhhmdewx	L'hospitalet De Llobregat	Spain
Crkvce Lfnp Bzqqsn	Lyon	France
Hsefvjer Vpfs dtbjvcya	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.08.2023
Spain	Recruiting	01.08.2023

Trial locations

Investigated drugs:

TNG462 is a new medication being studied to see if it can help treat certain types of cancer. It is being tested in patients who have advanced or metastatic solid tumors that have a specific genetic change called MTAP deletion. The study aims to find out how safe TNG462 is, how well patients can tolerate it, and whether it can help shrink or slow down the growth of these tumors. Researchers are also trying to determine the best dose of TNG462 to use in future studies. This medication is still in the early stages of research, so it is not yet available outside of clinical trials.

MTAP-deleted Advanced or Metastatic Solid Tumors – These tumors occur when there is a deletion of the MTAP gene in solid tumors, which can be found in various organs. The absence of the MTAP gene affects cellular metabolism, leading to uncontrolled cell growth. As the disease progresses, the tumors can grow larger and may spread to other parts of the body, a process known as metastasis. This spread can affect the function of the organs involved, leading to a range of symptoms depending on the location of the tumors. The progression of these tumors can vary widely among individuals, influenced by factors such as the type of solid tumor and the extent of MTAP deletion.

Trial ID:

2022-502645-99-00

Protocol code:

TNG462-C101

NCT ID:

NCT05732831

Trial Phase:

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

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Study on the Safety and Effectiveness of TNG462 for Patients with Advanced or Metastatic Solid Tumors with MTAP Deletion

What is this study about?

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