#1 Clinical Trials Search in Europe

N-(6-Amino-5-Methylpyridin-3-Yl)-2-((2R,5S)-2-(Benzo[D]Thiazol-5-Yl)-5-Methylpiperidin-1-Yl)-2-Oxoacetamide

This article discusses the clinical trials of TNG908, a new drug being tested for patients with advanced or metastatic solid tumors that are missing the MTAP gene. The study aims to determine the safety, tolerability, and potential anti-tumor effects of TNG908 in various types of cancers, including lung cancer, mesothelioma, sarcoma, and glioblastoma. The trials are designed to find the best dose and schedule for the drug while assessing its effectiveness in treating these challenging cancers.

Table of Contents

What is TNG908?

TNG908 is a new medication being developed to treat various types of advanced or metastatic solid tumors that have a specific genetic characteristic called MTAP deletion[1]. MTAP stands for Methylthioadenosine Phosphorylase, which is a gene that plays a role in how cells grow and divide. When this gene is missing (deleted) in cancer cells, it can make the cancer more aggressive, but it also creates a weakness that TNG908 is designed to target.

The full chemical name of TNG908 is N-(6-AMINO-5-METHYLPYRIDIN-3-YL)-2-((2R,5S)-2-(BENZO[D]THIAZOL-5-YL)-5-METHYLPIPERIDIN-1-YL)-2-OXOACETAMIDE[1]. It’s a mouthful, which is why it’s referred to more simply as TNG908. This medication comes in the form of a film-coated tablet that is taken by mouth[1].

How Does TNG908 Work?

TNG908 is a type of drug called a PRMT5 inhibitor[1]. PRMT5 is an enzyme that cancer cells with MTAP deletion rely on more heavily than normal cells. By blocking this enzyme, TNG908 aims to slow down or stop the growth of cancer cells while potentially having less effect on healthy cells.

The drug works by exploiting a vulnerability created when the MTAP gene is missing in cancer cells. This targeted approach is part of a growing trend in cancer treatment called precision medicine, where treatments are tailored to the specific genetic characteristics of a patient’s tumor.

What Conditions Does TNG908 Treat?

TNG908 is being studied for the treatment of several types of advanced or metastatic solid tumors that have the MTAP deletion. These include[1]:

  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is one of the most common forms of the disease.
  • Mesothelioma: A rare cancer that affects the lining of the lungs, chest wall, or abdomen.
  • Sarcoma: Cancers that develop in bones or soft tissues like muscles or fat.
  • Pancreatic ductal adenocarcinoma: The most common type of pancreatic cancer.
  • Glioblastoma multiforme (GBM): An aggressive type of brain cancer.
  • Other solid tumors: Including esophageal cancer, cholangiocarcinoma (bile duct cancer), urothelial cancer, and cancers of unknown primary origin.

It’s important to note that TNG908 is specifically for tumors that have the MTAP deletion, which can be determined through genetic testing of the tumor[1].

Clinical Trial Details

TNG908 is currently being studied in a clinical trial known as a Phase 1/2 trial[1]. This type of trial is designed to:

  1. Find the right dose of the medication (Phase 1)
  2. See how well it works in treating different types of cancers (Phase 2)

The trial is divided into two main parts:

Phase 1: Dose Escalation

In this part, researchers are testing different doses of TNG908 to find the safest and most effective dose. They start with a low dose (25 mg twice daily) and gradually increase it, carefully monitoring patients for any side effects[1].

Phase 2: Dose Expansion

Once the best dose is determined, more patients will be enrolled to further test the effectiveness of TNG908. This phase is divided into six groups, each focusing on a different type of cancer with the MTAP deletion[1].

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria. Some key requirements include[1]:

  • Being 18 years of age or older
  • Having a confirmed diagnosis of one of the cancers being studied
  • Having a tumor with a confirmed MTAP deletion
  • Having received prior standard treatments for their cancer
  • Having adequate organ function
  • Being able to swallow tablets

Patients who have previously been treated with a PRMT5 inhibitor are not eligible for this trial[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider:

Potential Benefits:

  • Access to a new treatment that may be effective against MTAP-deleted cancers
  • Close monitoring by healthcare professionals
  • Contributing to the advancement of cancer research

Potential Risks:

  • Unknown side effects
  • The treatment may not be effective for everyone
  • Time commitment for medical visits and tests

The researchers will be closely monitoring patients for any side effects and measuring how well the treatment works. They will be looking at things like how many patients’ tumors shrink (called the objective response rate), how long the treatment keeps working (duration of response), and how long patients live without their cancer getting worse (progression-free survival)[1].

Aspect Details
Drug Name TNG908 (N-(6-Amino-5-Methylpyridin-3-Yl)-2-((2R,5S)-2-(Benzo[D]Thiazol-5-Yl)-5-Methylpiperidin-1-Yl)-2-Oxoacetamide)
Study Type Phase 1/2, Multi-Center, Open-Label
Target Conditions MTAP-deleted advanced or metastatic solid tumors, including NSCLC, mesothelioma, sarcoma, pancreatic cancer, and glioblastoma
Primary Objectives Determine maximum tolerated dose, recommended Phase 2 dose, and assess anti-tumor activity
Administration Oral, film-coated tablet
Study Design Phase 1: Dose escalation; Phase 2: Dose expansion in 6 arms
Key Eligibility Adults with MTAP-deleted tumors, prior standard therapy, adequate organ function

FAQ

  • What is TNG908 and what is it being tested for? TNG908 is a new drug being tested for patients with advanced or metastatic solid tumors that are missing the MTAP gene. It's being evaluated for various types of cancers, including lung cancer, mesothelioma, sarcoma, pancreatic cancer, and glioblastoma.
  • What are the main goals of the clinical trials for TNG908? The main goals are to determine the safe and effective dose of TNG908, assess its safety and tolerability, and evaluate its potential anti-tumor activity in patients with MTAP-deleted advanced solid tumors.
  • How is the clinical trial structured? The trial is structured in two phases. Phase 1 involves dose escalation to find the right dose, while Phase 2 expands the study to evaluate TNG908 in specific cancer types at the selected dose.
  • Who is eligible to participate in the TNG908 clinical trials? Eligible participants are adults (18 years or older) with confirmed MTAP-deleted advanced solid tumors or relapsed/refractory glioblastoma, who have received prior standard therapy and have adequate organ function.
  • How is TNG908 administered to patients in the trial? TNG908 is administered orally as a film-coated tablet. The dosing schedule starts at 25 mg twice daily, with potential adjustments based on the study's findings.

Ongoing Clinical Trials on N-(6-Amino-5-Methylpyridin-3-Yl)-2-((2R,5S)-2-(Benzo[D]Thiazol-5-Yl)-5-Methylpiperidin-1-Yl)-2-Oxoacetamide

  • Study on the Safety and Effects of TNG908 in Patients with Advanced or Metastatic Solid Tumors Missing the MTAP Gene

    Not recruiting

    1 1 1
    Investigated drugs:
    France

Glossary

  • MTAP: MTAP stands for Methylthioadenosine Phosphorylase, a gene that is missing in some cancer cells. The absence of this gene is used to identify patients who might benefit from the drug being tested.
  • Solid Tumor: A solid tumor is an abnormal mass of tissue that doesn't contain cysts or liquid areas. Solid tumors may be benign (not cancerous) or malignant (cancerous).
  • Metastatic: Metastatic refers to cancer that has spread from its original site to other parts of the body.
  • Glioblastoma Multiforme (GBM): A fast-growing and aggressive brain tumor that forms from glial cells (cells that support nerve cells).
  • NSCLC: Non-Small Cell Lung Cancer, a type of lung cancer that is one of the most common forms of the disease.
  • Mesothelioma: A type of cancer that develops in the thin layer of tissue that covers many of the internal organs (known as the mesothelium).
  • Sarcoma: A type of cancer that begins in bones and in the soft (also called connective) tissues.
  • Pancreatic Ductal Adenocarcinoma: The most common type of pancreatic cancer, which starts in the ducts of the pancreas.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Karnofsky Performance Status: A standard way of measuring the ability of cancer patients to perform ordinary tasks.
  • DLT: Dose-Limiting Toxicity, side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
  • ORR: Overall Response Rate, the proportion of patients whose cancer shrinks or disappears after treatment.
  • PFS: Progression-Free Survival, the length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • CBR: Clinical Benefit Rate, the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-tng908-in-patients-with-advanced-or-metastatic-solid-tumors-missing-the-mtap-gene/