Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05732831

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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