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Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

NCT05275478•Tango Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants.

Detailed Description

This is a Phase 1/2 multi-center, open label study in solid tumor patients (including glioblastoma) who have a confirmed homozygous MTAP deletion in their tumor. The Phase 1 portion is a dose escalation study of oral TNG908 in patients with confirmed MTAP-deleted solid tumors. In Phase 2, 6 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG908. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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 or Karnofsky performance status score ≥70.
•3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
•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

Exclusion Criteria

•1. Known allergies, hypersensitivity, or intolerance to TNG908 or its excipients
•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 TNG908
•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
+6 more criteria

Locations (20)

University of California Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Florida Cancer Specialists & Research Institute

Lake Mary, Florida, United States

Northwestern University

Chicago, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Key Dates

Start Date

March 23, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

November 14, 2025

Enrollment

192

ESTIMATED participants

Conditions

Locally Advanced Solid Tumor

Interventions

TNG908

DRUG

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors

NCT07050459

Locally Advanced Solid Tumors

View study

RECRUITINGPHASE1

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

NCT06415487

Locally Advanced Solid TumorMetastatic Solid Tumor

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors