beta
Trial Radar AI
Clinical Trial NCT05275478 for Locally Advanced Solid Tumor is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors Phase 1, Phase 2 192 First-in-Human Dose Escalation Open-Label

Active, not recruiting
Clinical Trial NCT05275478 is designed to study Treatment for Locally Advanced Solid Tumor. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on 23 March 2022, with plans to enroll 192 participants. Led by Tango Therapeutics, Inc., it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 14 November 2025.
Brief 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...Show More
Official Title

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

Conditions
Locally Advanced Solid Tumor
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • TNG908-C101
NCT ID Number
NCT05275478
Start Date (Actual)
2022-03-23
Last Update Posted
2025-11-14
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
192
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Active, not recruiting
Keywords
MTAP deletion
PRMT5
cholangiocarcinoma
NSCLC
mesothelioma
MPNST
Tango
Glioblastoma multiforme
pancreatic
GBM
sarcoma
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDose Escalation
Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in NSCLC
Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in Mesothelioma
Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in Pancreatic Ductal Adenocarcinoma
Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in Sarcoma
Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in solid tumors
Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
ExperimentalDose Expansion in Glioblastoma
Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D
TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Phase 1:
To determine the MTD and dosing schedule of TNG908
28 days
Phase 2:
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 MeasureMeasure DescriptionTime Frame
Phase 1:
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
Phase 1 and 2:
To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs
28 days
Phase 1 and 2:
Area under the plasma concentration versus time curve (AUC)
16 days
Phase 1 and 2:
Time to achieve maximal plasma concentration (Tmax)
16 days
Phase 1 and 2:
Maximum observed plasma concentration (Cmax)
16 days
Phase 1 and 2:
Terminal elimination half-life (t1/2)
16 days
Phase 1 and 2:
Apparent total plasma clearance when dosed orally (CL/F)
16 days
Phase 1 and 2:
Apparent volume of distribution when dosed orally (Vz/F)
16 days
Phase 1 and 2:
SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908
28 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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

Tango Therapeutics, Inc. logoTango Therapeutics, Inc.6 active studies to explore
No contact data.
20 Study Locations in 2 Countries

California

University of California Los Angeles, Los Angeles, California, 90095, United States
University of California San Francisco, San Francisco, California, 94143, United States

Colorado

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, 80218, United States
Grand Valley Oncology, Grand Junction, Colorado, 81505, United States

Florida

Florida Cancer Specialists & Research Institute, Lake Mary, Florida, 32746, United States

Illinois

Northwestern University, Chicago, Illinois, 60611, United States
Carle Cancer Center, Urbana, Illinois, 61801, United States

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Missouri

Washington University, St Louis, Missouri, 63110, United States

New York

NYU Langone Health, New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10022, United States

Tennessee

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

Texas

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

Virginia

NEXT Oncology, Fairfax, Virginia, 22031, United States
Institut Bergonié, Bordeaux, 33000, France
Centre Léon Bérard, Lyon, 69373, France
EDOG Institut de Cancerologie de l'Ouest, Saint-Herblain, 44805, France
Institut Oncopole Claudius Regaud, Toulouse, 31059, France
Institute Gustav Roussy, Villejuif, 94805, France