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