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Tng462

A groundbreaking clinical trial is underway to assess the safety, tolerability, and potential anti-tumor effects of TNG462, a new drug designed for patients with advanced or metastatic solid tumors that have a specific genetic deletion called MTAP. This study combines TNG462, taken orally, with an established immunotherapy drug, pembrolizumab, to explore its effectiveness in various types of cancers.

Table of Contents

What is TNG462?

TNG462 is a new drug currently being studied for its potential to treat certain types of cancer. It is described as a selective PRMT5 inhibitor, which means it targets a specific protein in cancer cells[1]. This drug is taken orally, which means patients can swallow it as a pill or liquid, making it more convenient than some cancer treatments that require injections or infusions.

How Does TNG462 Work?

TNG462 works by inhibiting (blocking) a protein called PRMT5. This protein is often overactive in certain types of cancer cells, especially those with a specific genetic change called an MTAP deletion[1]. By blocking PRMT5, TNG462 may be able to slow down or stop the growth of cancer cells without affecting healthy cells as much as some other cancer treatments.

What Conditions Does TNG462 Treat?

TNG462 is being studied for the treatment of advanced or metastatic solid tumors that have an MTAP deletion[1]. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. “Advanced” means the cancer is in a later stage, and “metastatic” means it has spread from where it started to other parts of the body. The clinical trial is focusing on several specific types of cancer:

  • Non-small cell lung cancer (NSCLC): Both squamous and non-squamous types[1]
  • Mesothelioma: A type of cancer that affects the lining of the lungs, chest wall, or abdomen[1]
  • Pancreatic ductal adenocarcinoma: The most common type of pancreatic cancer[1]
  • Sarcoma: Cancers that develop in bones or soft tissues[1]
  • Other solid tumors with MTAP deletion[1]

Clinical Trial Overview

The clinical trial for TNG462 is a Phase 1/2 study, which means it’s in the early stages of testing in humans[1]. This trial is described as “first in human,” indicating that it’s the first time this drug is being tested in people. The study plans to enroll up to 159 participants with advanced or metastatic solid tumors that have an MTAP deletion[1].

Trial Phases and Objectives

The trial is divided into two main phases:

  1. Phase 1 (Dose Escalation): This phase aims to determine the safest and most effective dose of TNG462. Researchers will gradually increase the dose to find the maximum tolerated dose (MTD) and establish a dosing schedule[1].
  2. Phase 2 (Dose Expansion): In this phase, researchers will further evaluate the effectiveness of TNG462 at the dose determined in Phase 1. This phase includes five separate groups (or “arms”) for different types of MTAP-deleted tumors[1].

Safety and Effectiveness Measures

Throughout the trial, researchers will be monitoring several aspects of TNG462’s performance:

  • Safety and tolerability: They will track the frequency and severity of side effects (adverse events)[1].
  • Anti-tumor activity: Using imaging techniques, they will assess whether tumors shrink or stop growing in response to the treatment[1].
  • Pharmacokinetics: This involves studying how the drug moves through the body, including how quickly it’s absorbed, how long it stays in the system, and how it’s eliminated[1].
  • Biomarker analysis: Researchers will measure levels of a substance called SDMA in tumor tissue before and after treatment, which may help indicate how well the drug is working[1].

Who Can Participate?

This trial is specifically for patients with solid tumors that have a confirmed homozygous MTAP deletion. This means that both copies of the MTAP gene in the tumor cells are missing. Participants must have advanced or metastatic cancer, which typically means that previous treatments have not been successful in controlling the disease[1].

It’s important to note that this is an ongoing clinical trial, and TNG462 is not yet approved for general use. If you think you might be eligible for this trial, you should discuss it with your oncologist or healthcare provider. They can provide more information about the potential risks and benefits, and help determine if this trial might be appropriate for your specific situation.

Aspect Details
Drug Name TNG462
Drug Type Selective PRMT5 inhibitor
Administration Oral
Target Patients Those with MTAP-deleted advanced or metastatic solid tumors
Study Design Phase 1/2, multi-center, open-label
Study Phases Phase 1: Dose escalation, Phase 2: Dose expansion
Combination Therapy TNG462 alone and with pembrolizumab
Cancer Types Studied NSCLC, Mesothelioma, Pancreatic Ductal Adenocarcinoma, Sarcoma, Other solid tumors
Primary Outcomes Maximum Tolerated Dose, Dosing Schedule, Anti-neoplastic Activity
Secondary Outcomes Safety profile, Pharmacokinetics, SDMA levels in tumor tissue

FAQ

  • What is TNG462 and how does it work? TNG462 is a selective PRMT5 inhibitor, which means it targets a specific protein in cancer cells. It's taken orally and is being tested for its ability to fight tumors with a particular genetic feature called MTAP deletion.
  • Who can participate in this clinical trial? The trial is for patients with advanced or metastatic solid tumors that have a confirmed MTAP deletion. This includes various cancer types such as lung cancer, mesothelioma, pancreatic cancer, and sarcomas.
  • What is the structure of the clinical trial? The trial has two parts: Phase 1 is a dose escalation study to determine the safe dose, and Phase 2 involves expansion to test the drug in specific tumor types at the recommended dose.
  • Is TNG462 used alone or with other treatments? TNG462 is being tested both as a single agent and in combination with pembrolizumab, an immunotherapy drug that helps the immune system fight cancer cells.
  • What are the main goals of this clinical trial? The main goals are to determine the safe dose of TNG462, establish a dosing schedule, and assess its anti-cancer activity in patients with MTAP-deleted solid tumors, both alone and in combination with pembrolizumab.

Ongoing Clinical Trials on Tng462

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

    Recruiting

    1 1 1
    Investigated drugs:
    France Spain

  • Study of S095035 and TNG462 in adults with advanced or metastatic solid tumors with MTAP deletion

    Not recruiting

    1 1
    Investigated drugs:
    Denmark France Germany Italy Spain

Glossary

  • MTAP deletion: A genetic change in some cancer cells where the MTAP gene is missing. This deletion makes these cancer cells potentially more responsive to certain treatments.
  • PRMT5 inhibitor: A type of drug that blocks the action of PRMT5, a protein that can contribute to cancer growth. TNG462 is a selective PRMT5 inhibitor.
  • Pembrolizumab: An immunotherapy drug (also known as Keytruda) that helps the body's immune system detect and fight cancer cells.
  • Solid tumor: A mass of abnormal cells that doesn't contain cysts or liquid areas. Solid tumors can occur in many parts of the body, such as the lungs, breast, or pancreas.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Phase 1 trial: The first stage of testing a new treatment in humans, primarily to determine its safety and appropriate dosage.
  • Phase 2 trial: The second stage of testing, which aims to see if the treatment is effective against specific types of cancer.
  • Dose escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • RP2D: Recommended Phase 2 Dose – the dose determined to be safe and potentially effective, to be used in further testing.
  • RECIST: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.

References