Actively Recruiting
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Led by Tango Therapeutics, Inc. · Updated on 2026-04-13
191
Participants Needed
15
Research Sites
131 weeks
Total Duration
On this page
Sponsors
T
Tango Therapeutics, Inc.
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a tumor with a confirmed MTAP loss
- Is 18 years of age or older at the time of signing the main study informed consent form
- Has had progression or inadequate response to, or is intolerant of, approved standard of care therapy, or no standard of care therapy exists, or investigator deems standard care inappropriate
- Is able to swallow tablets
- Has adequate organ function based on local laboratory tests
- Has a 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 confirmed glioblastoma (IDH-wildtype) with radiographic evidence of progression or recurrence by RANO 2.0
- Has an ECOG performance status score of 0 to 1 or for glioblastoma has a Karnofsky performance status score of 70 or higher
You will not qualify if you...
- Is a female patient who is pregnant or breastfeeding
- Has impaired gastrointestinal function or disease that may significantly affect absorption of oral study treatments
- Has an active infection requiring systemic therapy
- Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
- In the expansion phase, has received prior treatment with a CDK4/6 inhibitor if receiving combination therapy
- Has clinically relevant cardiovascular disease
- Has a prior or ongoing clinically significant illness that could affect safety, study assessment, or protocol compliance
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5452
Actively Recruiting
2
University of California, Irvine
Irvine, California, United States, 92686
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90995
Actively Recruiting
4
University of California at San Francisco
San Francisco, California, United States, 94143-2202
Actively Recruiting
5
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
6
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611-2908
Actively Recruiting
8
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
10
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11065
Actively Recruiting
12
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5500
Actively Recruiting
15
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
T
Tab Cooney, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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