Study on TNG260 and an Anti-PD Antibody for Solid Tumors with STK11 Mutation

Sponsor: Tango Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05887492

Provider View

This clinical trial is exploring a new treatment combining TNG260 and pembrolizumab for patients with advanced solid tumors that have a specific STK11 mutation. The study aims to find the best dose, assess safety, and evaluate how the treatment works in the body.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment using TNG260, a CoREST inhibitor, together with pembrolizumab in patients who have advanced solid tumors with a known STK11 mutation. The study will determine the best dose for future trials, evaluate the safety and tolerability of the treatment, understand how TNG260 is processed in the body, and assess its initial effectiveness against cancer. Participants will continue receiving the treatment until they experience significant side effects, their cancer worsens, or they choose to stop participating.

Description

This is a first-in-human study, meaning it's the first time TNG260 is being tested in people. The study is in Phase 1/2 and is open-label, which means both the researchers and participants know what treatment is being given. It is being conducted at multiple centers and involves gradually increasing the dose of TNG260 to find the maximum dose that can be tolerated safely. The study will also determine the recommended dose for Phase 2 trials. Researchers will evaluate the safety and tolerability of the treatment, how TNG260 is absorbed and processed in the body, and its effectiveness in treating cancer. Participants with locally advanced or metastatic solid tumors that have an STK11 mutation will receive oral doses of TNG260 along with a standard dose of pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have measurable cancer based on standard criteria.
  • Have a solid tumor with a documented STK11 mutation, identified through a validated test.
  • Have a confirmed diagnosis of a locally advanced or metastatic solid tumor.
  • Have adequate organ function as determined by local lab tests.
  • Have adequate liver and kidney function as determined by local lab tests.
  • Women must have a negative pregnancy test at screening.
  • Must provide written informed consent according to local guidelines.

Exclusion Criteria

  • Known allergies or intolerance to TNG260, PD-1 antibody, or their ingredients.
  • Have an uncontrolled illness that would prevent compliance with the study.
  • Have an active infection requiring treatment.
  • Currently participating in another study of an investigational drug or device.
  • Have a gastrointestinal condition that affects the absorption of oral TNG260.
  • Have another active or prior cancer.
  • Have cancer that has spread to the brain with worsening neurological symptoms.
  • Have active liver disease from any cause.
  • Have significant heart disease.
  • Women who are pregnant or breastfeeding.

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