Study Stopped
Sponsor Decision - Business Decisions
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
1 other identifier
interventional
110
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedApril 15, 2026
April 1, 2026
3.8 years
February 18, 2022
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Phase 1:
16 weeks
Phase 1 and 2:
28 days
Phase 1 and 2:
16 days
Phase 1 and 2:
16 days
Phase 1 and 2:
16 days
- +4 more secondary outcomes
Study Arms (7)
Dose Escalation
EXPERIMENTALParticipants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD
Dose Expansion in NSCLC
EXPERIMENTALParticipants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D
Dose Expansion in Mesothelioma
EXPERIMENTALParticipants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D
Dose Expansion in Pancreatic Ductal Adenocarcinoma
EXPERIMENTALParticipants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D
Dose Expansion in Sarcoma
EXPERIMENTALParticipants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D
Dose Expansion in solid tumors
EXPERIMENTALParticipants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D
Dose Expansion in Glioblastoma
EXPERIMENTALParticipants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D
Interventions
TNG908, a selective PRMT5 inhibitor, will be administered orally
Eligibility Criteria
You may qualify if:
- Age: ≥18 years-of-age at the time of signature of the main study ICF
- Performance status: ECOG Performance Score of 0 to 1 or Karnofsky performance status score ≥70.
- Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
- Prior standard therapy, as available
- 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.
- Adequate organ function/reserve per local labs
- Adequate liver function per local labs
- Adequate renal function per local labs
- Negative serum pregnancy test result at screening
- Written informed consent must be obtained according to local guidelines
You may not qualify if:
- Known allergies, hypersensitivity, or intolerance to TNG908 or its excipients
- Uncontrolled intercurrent illness that will limit compliance with the study requirements
- Active infection requiring systemic therapy
- Currently participating in or has planned participation in a study of another investigational agent or device
- Impairment of GI function or disease that may significantly alter the absorption of oral TNG908
- Active prior or concurrent malignancy.
- Central nervous system metastases associated with progressive neurological symptoms
- Current active liver disease from any cause
- Known to be HIV positive, unless all of the following criteria are met:
- CD4+ count ≥300/μL
- Undetectable viral load
- Receiving highly active antiretroviral therapy
- Clinically relevant cardiovascular disease
- A female patient who is pregnant or lactating
- Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California San Francisco
San Francisco, California, 94143, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, 32746, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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
Related Publications (1)
Briggs KJ, Cottrell KM, Tonini MR, Tsai A, Zhang M, Whittington DA, Zhang W, Lombardo SA, Yoda S, Wilker EW, Meier SR, Yu Y, Teng T, Huang A, Maxwell JP. TNG908 is a brain-penetrant, MTA-cooperative PRMT5 inhibitor developed for the treatment of MTAP-deleted cancers. Transl Oncol. 2025 Feb;52:102264. doi: 10.1016/j.tranon.2024.102264. Epub 2025 Jan 4.
PMID: 39756156DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maxim Pimkin, MD, PhD
Tango Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 11, 2022
Study Start
March 23, 2022
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share