Centre Leon Berard
Verified
Lyon, France
Not recruitingRare disease
Study on the Safety and Effects of TNG908 in Patients with Advanced or Metastatic Solid Tumors Missing the MTAP Gene
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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 the effects of a new treatment called TNG908 for patients with certain types of advanced or metastatic solid tumors. These tumors have a specific genetic change known as MTAP deletion. The study includes various types of cancers such as non-small cell lung cancer, mesothelioma, sarcoma, pancreatic cancer, and a type of brain cancer called glioblastoma multiforme. The purpose of the study is to evaluate the safety and initial effectiveness of TNG908 in treating these cancers.
The study is divided into two phases. In the first phase, different doses of TNG908 will be tested to determine the safest and most effective dose. In the second phase, the focus will be on assessing how well TNG908 works in shrinking the tumors. Participants will take TNG908 in the form of a film-coated tablet, which is taken orally. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient.
Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study aims to gather important information about the potential benefits and risks of TNG908 for treating these specific types of cancer. The trial is expected to continue until September 2025, providing valuable insights into the treatment of MTAP-deleted tumors.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Must be at least 18 years old at the time of signing the main study consent form.
- Must have a good general health status, which is measured by specific performance scores:
- For patients with solid tumors other than a specific type of brain tumor called R/R GBM, a score of 0 to 1 on the ECOG scale is required. This scale measures how well a person can perform daily activities.
- For patients with R/R GBM, a score of 70 or higher on the Karnofsky scale is needed. This scale also measures the ability to carry out daily activities.
- Must have a confirmed diagnosis of a locally advanced, metastatic, or unresectable solid tumor, or for those with R/R GBM, must have this specific type of brain tumor.
- Must have received standard treatment options that are available for their condition.
- Must have a specific genetic change in their tumor called a **bi-allelic (homozygous) deletion of MTAP**, which can be detected by certain tests.
- Must have adequate organ function, which means the organs are working well enough, as shown by local lab tests.
- Must have adequate liver function, as shown by local lab tests.
- Must have adequate kidney function, as shown by local lab tests.
- If female, must have a negative pregnancy test result at the time of screening.
- Must be able to swallow tablets.
- Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it, according to local guidelines.
Who cannot join the trial?
8 criteria
- Patients who have not been diagnosed with **locally advanced** or **metastatic** **MTAP-deleted** solid tumors. **Locally advanced** means the cancer has spread from where it started to nearby tissue or lymph nodes. **Metastatic** means the cancer has spread to other parts of the body. **MTAP-deleted** refers to a specific genetic change in the tumor.
- Patients who do not have **MTAP-deleted** **relapsed** or **refractory** Grade 4 astrocytoma or glioblastoma multiforme. **Relapsed** means the cancer has returned after treatment. **Refractory** means the cancer does not respond to treatment.
- Patients who do not have **locally advanced** or **metastatic** **MTAP-deleted** squamous or nonsquamous **NSCLC**. **NSCLC** stands for non-small cell lung cancer, which is a type of lung cancer.
- Patients who do not have **locally advanced** or **metastatic** **MTAP-deleted** mesothelioma. Mesothelioma is a type of cancer that affects the lining of the lungs or abdomen.
- Patients who do not have **locally advanced** or **metastatic** **MTAP-deleted** sarcoma. Sarcoma is a type of cancer that begins in the bones or soft tissues.
- Patients who do not have **locally advanced** or **metastatic** **MTAP-deleted** pancreatic ductal adenocarcinoma or adenosquamous carcinoma with predominantly adenocarcinoma histology. These are types of pancreatic cancer.
- Patients who do not have other **locally advanced** or **metastatic** **MTAP-deleted** solid tumors.
- Patients who do not have **MTAP-deleted** **relapsed** or **refractory** glioblastoma multiforme.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Institut Gustave Roussy
VerifiedVillejuif, FranceInstitut de Cancérologie de l'Ouest
VerifiedSaint-Herblain, France
Trial locations
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Investigated drugs
TNG908 is an investigational medication being studied for its potential to treat advanced or metastatic solid tumors that have a specific genetic deletion known as MTAP-deletion. The trial aims to evaluate the safety and tolerability of this medication, as well as its preliminary effectiveness in reducing tumor size or slowing tumor growth in affected patients.
What is already known about the treatment
TNG908 – TNG908 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating certain advanced or metastatic solid tumors that have a specific genetic deletion known as MTAP-deletion. The medication is in the early stages of clinical research, with ongoing studies evaluating its safety, tolerability, and preliminary anti-tumor activity. TNG908 is primarily being investigated for its effectiveness in treating various types of MTAP-deleted cancers, including non-small cell lung cancer, mesothelioma, sarcoma, pancreatic cancer, and glioblastoma multiforme. The drug works by targeting specific molecular pathways that are altered in MTAP-deleted tumors, aiming to inhibit tumor growth. It is classified as an anti-cancer agent, focusing on targeted therapy for genetically defined cancer types.
Investigated diseases
Astrocytoma
Astrocytoma is a type of brain tumor that originates from star-shaped brain cells called astrocytes. It can vary in its growth rate, with some forms being slow-growing and others more aggressive. As the tumor grows, it can cause symptoms such as headaches, seizures, and changes in behavior or personality. The tumor may infiltrate surrounding brain tissue, making it challenging to remove completely. Over time, it can lead to increased pressure within the skull, affecting brain function.
Glioblastoma Multiforme
Glioblastoma multiforme is an aggressive type of cancer that occurs in the brain or spinal cord. It arises from astrocytes, the supportive tissue of the brain, and is known for its rapid growth and tendency to invade nearby brain tissue. Symptoms often include headaches, nausea, vomiting, and neurological deficits such as weakness or speech difficulties. The tumor's location and size can significantly impact the severity of symptoms. It is characterized by its heterogeneous appearance and necrotic areas within the tumor.
Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer is the most common type of lung cancer, accounting for a majority of cases. It typically grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, such as the bones or brain. The cancer is often associated with a history of smoking, although non-smokers can also develop it.
Mesothelioma
Mesothelioma is a rare cancer that affects the lining of the lungs, abdomen, or heart. It is primarily caused by exposure to asbestos fibers. Symptoms can include chest pain, shortness of breath, and abdominal swelling. The disease tends to develop slowly, often taking decades after exposure to asbestos to appear. As it progresses, it can lead to significant respiratory or digestive issues.
Sarcoma
Sarcoma is a type of cancer that originates in the bones and soft tissues, such as fat, muscle, and blood vessels. It can occur anywhere in the body and is known for its diverse forms and behaviors. Symptoms depend on the tumor's location and may include a noticeable lump, pain, or swelling. Sarcomas can grow and spread to other parts of the body, complicating treatment. They are relatively rare compared to other types of cancer.
Pancreatic Ductal Adenocarcinoma
Pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It is known for its aggressive nature and tendency to spread quickly to nearby organs. Symptoms often include jaundice, weight loss, and abdominal pain. The cancer can obstruct the bile duct, leading to digestive issues. Its location deep within the abdomen makes early detection challenging.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-511976-34-00Protocol codeTNG908-C101Estimated enrolment192 patientsSponsorTango Therapeutics Inc.
sourced from the EU Clinical Trials Register and site verification
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