ClinicalTrials.gg
TerminatedNCT05275478Updated Apr 15, 2026

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

A Phase 1/2 interventional study of TNG908 in Locally Advanced Solid Tumor, sponsored by Tango Therapeutics, Inc.. Terminated at 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Tango Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor Decision - Business Decisions
Phase
Phase 1/2
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Locally Advanced Solid Tumor

Keywords

  • MTAP deletion
  • PRMT5
  • cholangiocarcinoma
  • NSCLC
  • mesothelioma
  • MPNST
  • Tango
  • Glioblastoma multiforme
  • pancreatic
  • GBM
  • sarcoma
03

In context

Cholangiocarcinoma

824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.

This study's enrollment of 110 is above the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Tango Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: ≥18 years-of-age at the time of signature of the main study ICF
  2. Performance status: Performance Score of 0 to 1 or performance status score ≥70.
  3. Confirmed histologic or cytologic diagnosis of a locally advanced, , 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 must be obtained according to local guidelines

Exclusion criteria

Exclusion Criteria:

  1. Known allergies, , or intolerance to TNG908 or its
  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 agent or device
  5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG908
  6. Active prior or concurrent .
  7. Central nervous system associated with progressive neurological symptoms
  8. Current active liver disease from any cause
  9. Known to be positive, unless all of the following criteria are met:

    1. ≥300/μL
    2. Undetectable viral load
    3. Receiving highly active antiretroviral therapy
  10. 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, , 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
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Dose Escalation

    Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD

    Drug: TNG908

  • Experimental
    Dose Expansion in NSCLC

    Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D

    Drug: TNG908

  • Experimental
    Dose Expansion in Mesothelioma

    Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D

    Drug: TNG908

  • Experimental
    Dose Expansion in Pancreatic Ductal Adenocarcinoma

    Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D

    Drug: TNG908

  • Experimental
    Dose Expansion in Sarcoma

    Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D

    Drug: TNG908

  • Experimental
    Dose Expansion in solid tumors

    Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D

    Drug: TNG908

  • Experimental
    Dose Expansion in Glioblastoma

    Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D

    Drug: TNG908

Interventions

  • DrugTNG908

    TNG908, a selective PRMT5 inhibitor, will be administered orally

06

What researchers measure

Primary outcomes

  1. Phase 1:

    To determine the MTD and dosing schedule of TNG908

    Time frame: 28 days

  2. 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

    Time frame: 16 weeks

Secondary outcomes

  1. 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

    Time frame: 16 weeks

  2. Phase 1 and 2:

    To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs

    Time frame: 28 days

  3. Phase 1 and 2:

    Area under the plasma concentration versus time curve (AUC)

    Time frame: 16 days

  4. Phase 1 and 2:

    Time to achieve maximal plasma concentration (Tmax)

    Time frame: 16 days

  5. Phase 1 and 2:

    Maximum observed plasma concentration (Cmax)

    Time frame: 16 days

  6. Phase 1 and 2:

    Terminal elimination half-life (t1/2)

    Time frame: 16 days

  7. Phase 1 and 2:

    Apparent total plasma clearance when dosed orally (CL/F)

    Time frame: 16 days

  8. Phase 1 and 2:

    Apparent volume of distribution when dosed orally (Vz/F)

    Time frame: 16 days

  9. Phase 1 and 2:

    SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908

    Time frame: 28 days

07

Study locations

20 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 39756156 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Dec 2025, 45 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2022
First posted
Mar 11, 2022
StartActual
Mar 23, 2022
Primary completionActual
Dec 30, 2025
CompletionActual
Dec 30, 2025
Last update
Apr 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05275478
Lead sponsor
Tango Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 11, 2022
Start date
Mar 23, 2022
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025
Last update
Apr 15, 2026

Study contacts

Maxim Pimkin, MD, PhD
study director · Tango Therapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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