Study on the Safety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors

Sponsor: Tango Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05732831

Provider View

This clinical trial is testing a new drug, TNG462, 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 159 participants and will be conducted in two parts.

Patient Parameters

Program Overview

This study is the first to test TNG462 in humans, focusing on patients with advanced or metastatic solid tumors that have an MTAP deletion. The trial is divided into two parts: the first part will determine the best dose of TNG462, and the second part will expand the study to include specific types of MTAP-deleted tumors. TNG462 is taken orally, and participants who tolerate the drug well may continue treatment until their disease progresses.

Description

This is a Phase 1/2 study conducted at multiple centers, involving patients with solid tumors that have a confirmed MTAP deletion. In Phase 1, the study will test different doses of TNG462 to find the safest and most effective dose. In Phase 2, the study will expand to include five groups of patients with specific types of MTAP-deleted tumors, all receiving the recommended dose of TNG462. Participants who respond well to the treatment and do not experience severe side effects may continue taking the drug until their cancer worsens.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good performance status, meaning fully active or only slightly restricted in physical activities.
  • Have a confirmed diagnosis of a locally advanced, metastatic, or inoperable solid tumor.
  • Have received standard treatments available for their cancer.
  • Have a confirmed MTAP deletion in their tumor, as detected by specific tests.
  • Have adequate organ function based on local lab tests.
  • Have adequate 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 to participate.

Exclusion Criteria

  • Have known allergies or intolerance to TNG462 or its ingredients.
  • Have an uncontrolled illness that would interfere with the study.
  • Have an active infection requiring treatment.
  • Are participating in another study of an investigational drug or device.
  • Have a condition affecting the digestive system that could alter the absorption of TNG462.
  • Have another active or prior cancer.
  • Have brain metastases causing worsening neurological symptoms.
  • Have active liver disease.
  • Are HIV positive, unless specific criteria are met, including a stable condition and treatment.
  • Have significant heart disease.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to comply with study visits, drug administration, tests, or procedures.
  • Have a significant medical condition that may affect safety or study results.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.