Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Description

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

Locally Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Condition
Locally Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Grand Junction

Grand Valley Oncology, Grand Junction, Colorado, United States, 81505

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Chicago

University Chicago Medicine, Chicago, Illinois, United States, 60637

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Cancer Center, Detroit, Michigan, United States, 48202

New York

New York University Langone Health, New York, New York, United States, 10016

Nashville

Sarah Cannon Tennessee Oncology, Nashville, Tennessee, United States, 37203

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Salt Lake City

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age: ≥18 years-of-age at the time of signature of the main study ICF
  • 2. Performance status: ECOG Performance Score of 0 to 1
  • 3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
  • 4. Prior standard therapy, as available
  • 5. Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC.
  • 6. Adequate organ function/reserve per local labs
  • 7. Adequate liver function per local labs
  • 8. Adequate renal function per local labs
  • 9. Negative serum pregnancy test result at screening
  • 10. Written informed consent must be obtained according to local guidelines
  • 1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
  • 2. Uncontrolled intercurrent illness that will limit compliance with the study requirements
  • 3. Active infection requiring systemic therapy
  • 4. Currently participating in or has planned participation in a study of another investigational agent or device
  • 5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
  • 6. Active prior or concurrent malignancy.
  • 7. Central nervous system metastases associated with progressive neurological symptoms
  • 8. Current active liver disease from any cause
  • 9. Known to be HIV positive, unless all of the following criteria are met:
  • 1. CD4+ count ≥300/μL
  • 2. Undetectable viral load
  • 3. Receiving highly active antiretroviral therapy
  • 10. Clinically relevant cardiovascular disease
  • 11. A female patient who is pregnant or lactating
  • 12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
  • 13. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tango Therapeutics, Inc.,

Ellen Hooper, MD, STUDY_DIRECTOR, Tango Therapeutics, Inc.

Study Record Dates

2026-09