Actively Recruiting
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Led by Tango Therapeutics, Inc. · Updated on 2026-04-21
225
Participants Needed
26
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.
CONDITIONS
Official Title
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent
- ECOG Performance Score of 0 to 1
- Histologic or cytologic diagnosis of a locally advanced, metastatic, or unresectable solid tumor
- Prior standard therapy received if available
- Confirmed bi-allelic (homozygous) MTAP deletion in tumor by next-generation sequencing or absence of MTAP protein by IHC
- Adequate organ, liver, and renal function based on local laboratory tests
- Negative serum pregnancy test at screening
- Written informed consent obtained according to local guidelines
You will not qualify if you...
- Known allergies, hypersensitivity, or intolerance to TNG462, pembrolizumab, or their excipients
- Uncontrolled illness limiting study compliance
- Active infection requiring systemic therapy
- Participation in another investigational study or planned participation
- Gastrointestinal impairment affecting oral drug absorption
- Active prior or concurrent malignancy
- CNS metastases with progressive neurological symptoms
- Active liver disease of any cause
- HIV positive without controlled disease (CD4+ count ≥300/µL, undetectable viral load, receiving antiretroviral therapy)
- Clinically relevant cardiovascular disease
- Pregnant or lactating female
- Unwilling or unable to comply with study visits, drug administration, tests, biopsies, or restrictions
- Prior or ongoing illness or condition that may affect safety or study assessments according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
Actively Recruiting
3
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States, 32746
Completed
4
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
University Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
7
Midwestern Regional Medical Center, City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Henry Ford Cancer Center
Detroit, Michigan, United States, 48202
Actively Recruiting
11
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
12
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
15
Next Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
CHU de Brest
Brest, France, 29200
Actively Recruiting
17
Centre Berard Leon
Lyon, France, 69373
Actively Recruiting
18
Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS
Saint-Herblain, France, 44805
Actively Recruiting
19
Institute Gustav Roussy
Villejuif, France, 94805
Actively Recruiting
20
Vall d'Hebron Barcelona Hospital
Barcelona, Catalonia, Spain
Actively Recruiting
21
Hospital HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
22
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
23
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
24
Hospital de Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
25
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
26
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
M
Maxim Pimpkin, 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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