Study on the Safety and Tolerability of TNG908 for Patients with MTAP-deleted Solid Tumors

Sponsor: Tango Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05275478

Provider View

This clinical trial is testing a new drug, TNG908, to see if it is safe and well-tolerated in patients with advanced solid tumors that have a specific genetic deletion called MTAP. The study will involve up to 192 participants and will be conducted in two parts.

Patient Parameters

Program Overview

This study is the first of its kind to test TNG908, a new drug taken by mouth, in patients with advanced or metastatic solid tumors that have an MTAP deletion. The study is divided into two parts: the first part will determine the best dose of TNG908, and the second part will expand to include more patients with specific types of MTAP-deleted tumors. Participants who can tolerate the drug may continue treatment until their disease progresses.

Description

This clinical trial is a Phase 1/2 study conducted at multiple centers. It is open to patients with solid tumors, including glioblastoma, who have a confirmed MTAP deletion in their tumor. In Phase 1, the study will test different doses of TNG908 to find the safest and most effective dose. In Phase 2, the study will expand to include six groups of patients with specific types of MTAP-deleted tumors, all receiving the recommended dose of TNG908. Participants who tolerate the drug well may continue treatment until their cancer worsens.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score indicating they are fully active or have some restrictions but can still perform light work.
  • Must have a confirmed diagnosis of an advanced, metastatic, or inoperable solid tumor, or for glioblastoma, have recurrent or resistant disease.
  • Must have received standard treatment options if available.
  • Must have a confirmed MTAP deletion in their tumor through specific tests.
  • Must have adequate organ, liver, and kidney function based on local lab tests.
  • Women must have a negative pregnancy test before starting the study.
  • Must provide written informed consent according to local guidelines.

Exclusion Criteria

  • Known allergies or intolerance to TNG908 or its ingredients.
  • Have an uncontrolled illness that would prevent following the study requirements.
  • Have an active infection needing treatment.
  • Currently in another study or planning to join one.
  • Have a digestive issue that affects how the body absorbs TNG908.
  • Have another active or previous cancer.
  • Have brain metastases causing worsening neurological symptoms.
  • Have active liver disease.
  • Known to be HIV positive unless specific health criteria are met.
  • Have significant heart disease.
  • Women who are pregnant or breastfeeding.
  • Unwilling or unable to follow study visits, take the drug, or complete tests and procedures.
  • Have a significant illness or condition that may affect safety or study results.

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