Back to Trials
NCT06810544PHASE1, PHASE2Recruiting

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

Tango Therapeutics, Inc.

Start Date

3/24/2025

Completion Date

9/30/2027

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.

Detailed Description

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed MTAP loss in their tumor. The Phase 1 portion is a dose escalation study of oral TNG456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed MTAP loss. In the Phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the RP2D(s) of TNG456 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has a tumor with a confirmed MTAP loss * Is ≥18 years of age at the time of signature of the main study ICF * Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate. * Is able to swallow tablets * Adequate Organ function/reserve per local labs * Negative serum pregnancy test result at screening * Has an ECOG performance status score of 0 to 1 * Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0. * Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70. Exclusion Criteria: * A female patient is who is pregnant or breastfeeding * Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s) * Has an active infection requiring systemic therapy * Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor * Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor * Clinically relevant cardiovascular disease * Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol

Interventions

DRUG

TNG456

DRUG

abemaciclib

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Non Small Cell Lung CancerGlioma Glioblastoma MultiformeGlioma, MalignantSolid TumorNon-Small Cell AdenocarcinomaLung CancerBrain Tumor

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona 85259-5452

United States

University of California, Irvine

Irvine, California 92686

United States

University of California Los Angeles

Los Angeles, California 90995

United States

University of California at San Francisco

San Francisco, California 94143-2202

United States

Sibley Memorial Hospital

Washington D.C., District of Columbia 20016

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611-2908

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic Cancer Center

Rochester, Minnesota 55905-0001

United States

NYU Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 11065

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah 84112-5500

United States

NEXT Virginia

Fairfax, Virginia 22031

United States