RecruitingPhase 1Phase 2NCT06810544

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Sponsor

Tango Therapeutics, Inc.

Enrollment

191 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Non-small Cell Lung Cancer Solid Tumor Brain Tumor Glioma, Malignant Glioma Glioblastoma Multiforme Non-Small Cell Adenocarcinoma

Summary

This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing TNG456, a new cancer drug, both on its own and in combination with other treatments. It is an early-stage trial focused on safety, dosing, and how the drug behaves in the body. **You may be eligible if...** - You have an advanced or treatment-resistant solid tumor or blood cancer - You have already tried standard treatments without success - You are in good enough general health to tolerate an experimental treatment - You meet the lab values and organ function requirements **You may NOT be eligible if...** - You have serious uncontrolled infections or other active illnesses - You have had certain prior treatments that could interfere with TNG456 - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems 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

DRUGTNG456

A selective PRMT5 inhibitor

DRUGabemaciclib

A kinase inhibitor

Locations(15)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

University of California, Irvine

Irvine, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California at San Francisco

San Francisco, California, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06810544

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