RecruitingPhase 1Phase 2NCT05732831

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

Sponsor

Tango Therapeutics, Inc.

Enrollment

225 participants

Start Date

May 26, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Solid Tumor

Summary

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called TNG462 in people with advanced or metastatic solid tumours that have a specific genetic deletion called MTAP. Many cancers — including certain lung, pancreatic, and bladder cancers — can have this deletion, and TNG462 is designed to specifically target tumour cells with this feature. The study aims to find the right dose and assess safety. **You may be eligible if...** - You are 18 years or older - You have an advanced, metastatic, or inoperable solid tumour - Your tumour has been confirmed to have a bi-allelic MTAP deletion (by genetic testing) - You have already tried available standard treatments - Your kidneys, liver, and other organs are functioning adequately **You may NOT be eligible if...** - You have an allergy to TNG462 or pembrolizumab (if joining a combination arm) - You have an active or uncontrolled infection requiring treatment - You have active brain metastases causing neurological symptoms - You have active liver disease - You are HIV positive (unless well controlled with treatment) - You are pregnant or breastfeeding - You are currently in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNG462

TNG462, a selective PRMT5 inhibitor, will be administered orally

DRUGPembrolizumab

An anti PD-1 antibody, will be administered intravenously

Locations(26)

Stanford University

Palo Alto, California, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Florida Cancer Specialists & Research Institute

Lake Mary, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University Chicago Medicine

Chicago, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Midwestern Regional Medical Center, City of Hope Chicago

Zion, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer Center

Detroit, Michigan, United States

New York University Langone Health

New York, New York, United States

Sarah Cannon Tennessee Oncology

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Next Oncology Virginia

Fairfax, Virginia, United States

CHU de Brest

Brest, France

Centre Berard Leon

Lyon, France

Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS

Saint-Herblain, France

Institute Gustav Roussy

Villejuif, France

Vall d'Hebron Barcelona Hospital

Barcelona, Catalonia, Spain

Hospital HM Nou Delfos

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital de Sanchinarro

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT05732831

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