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

April 10, 2026 updated by: Tango Therapeutics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Institut Bergonié
      • Lyon, France, 69373
        • Centre léon bérard
      • Saint-Herblain, France, 44805
        • EDOG Institut de Cancerologie de l'Ouest
      • Toulouse, France, 31059
        • Institut Oncopole Claudius Regaud
      • Villejuif, France, 94805
        • Institute Gustav Roussy
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at HealthONE
      • Grand Junction, Colorado, United States, 81505
        • Grand Valley Oncology
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Florida Cancer Specialists & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Oncology

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in NSCLC
Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in Mesothelioma
Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in Glioblastoma
Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in Pancreatic Ductal Adenocarcinoma
Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in Sarcoma
Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Experimental: Dose Expansion in solid tumors
Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D
Drug: TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1:
Time Frame: 28 days
To determine the MTD and dosing schedule of TNG908
28 days
Phase 2:
Time Frame: 16 weeks
To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1 or modified RANO criteria
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 and 2:
Time Frame: 28 days
To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs
28 days
Phase 1 and 2:
Time Frame: 16 days
Area under the plasma concentration versus time curve (AUC)
16 days
Phase 1 and 2:
Time Frame: 16 days
Time to achieve maximal plasma concentration (Tmax)
16 days
Phase 1 and 2:
Time Frame: 16 days
Maximum observed plasma concentration (Cmax)
16 days
Phase 1 and 2:
Time Frame: 16 days
Terminal elimination half-life (t1/2)
16 days
Phase 1 and 2:
Time Frame: 16 days
Apparent total plasma clearance when dosed orally (CL/F)
16 days
Phase 1 and 2:
Time Frame: 16 days
Apparent volume of distribution when dosed orally (Vz/F)
16 days
Phase 1 and 2:
Time Frame: 28 days
SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908
28 days
Phase 1:
Time Frame: 16 weeks
To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST or mRECIST v1.1or modified RANO criteria
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tango Therapeutics, Inc.

Investigators

  • Study Director: Maxim Pimkin, MD, PhD, Tango Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNG908-C101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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