Actively Recruiting
Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Alone and 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
26 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
Researchers are evaluating the safety, tolerability, and early antitumor effects of TNG456 alone and combined with abemaciclib in patients with advanced or metastatic solid tumors that have a confirmed MTAP loss. This is a Phase 1/2, multi-center, open-label study that includes a dose escalation phase and a dose expansion phase focusing on specific tumor types. The study plans to enroll up to 191 participants to better understand treatment options for these tumor conditions. The study involves two main parts: an initial dose escalation phase where solid tumor patients receive increasing doses of oral TNG456 alone or with oral abemaciclib to find the maximum tolerated dose, followed by a dose expansion phase where six groups of patients with confirmed MTAP loss in various tumor types receive TNG456 alone or in combination at the recommended dose. Participants who tolerate treatment may continue until their disease progresses. During the trial, participants will undergo regular assessments including monitoring for side effects, measuring tumor response using RECIST v1.1 or RANO 2.0 criteria, and tracking drug levels in the body. The primary outcomes include determining the maximum tolerated dose in Phase 1 and assessing antitumor activity over 18 weeks in Phase 2. Safety and drug concentration will be closely observed throughout the study. Participation may last until disease progression or other study endpoints are reached.
CONDITIONS
Brief 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 consent
- Has had progression, inadequate response, or intolerance to approved standard therapy, no standard therapy exists, or standard therapy is not appropriate
- Is able to swallow tablets
- Has adequate organ function per local lab tests
- Has a negative serum pregnancy test at screening
- Has an ECOG performance status of 0 to 1
- Has measurable disease per RECIST v1.1 or confirmed glioblastoma with radiographic progression per RANO 2.0
- Has Karnofsky performance status score of 70 or higher for glioblastoma patients
You will not qualify if you...
- Female patients who are pregnant or breastfeeding
- Has impaired gastrointestinal function or disease affecting absorption of oral treatment
- Has an active infection requiring systemic therapy
- Has received prior treatment with a PRMT5 inhibitor or MAT2A inhibitor
- In expansion phase receiving combination therapy, has received prior CDK4/6 inhibitor treatment
- Has clinically relevant cardiovascular disease
- Has a prior or ongoing serious illness that may affect safety, study assessments, or protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral TNG456 alone or in combination with oral abemaciclib. Treatment continues until disease progression or unacceptable toxicity.
Visits occur each cycle for assessments and medication dispensing
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
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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