Locally Advanced Solid TumorPhase 1/2NCT05275478
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
A Phase 1/2 study testing TNG908 in people with Locally Advanced Solid Tumor, run by Tango Therapeutics, Inc. at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor
- What is being tested?
- TNG908
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 23 Mar 2022to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States15 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
NEXT Oncology
Fairfax, Virginia, 22031
Grand Valley Oncology
Grand Junction, Colorado, 81505
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, 32746
University of California Los Angeles
Los Angeles, California, 90095
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, 37203
NYU Langone Health
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
University of California San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
Carle Cancer Center
Urbana, Illinois, 61801
France5 sites
Institut Bergonié
Bordeaux, 33000
Centre Léon Bérard
Lyon, 69373
EDOG Institut de Cancerologie de l'Ouest
Saint-Herblain, 44805
Institut Oncopole Claudius Regaud
Toulouse, 31059
Institute Gustav Roussy
Villejuif, 94805
About this study
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
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.
- Conditions
- Locally Advanced Solid Tumor
- Being tested
- TNG908
- Keywords
- MTAP deletion, PRMT5, cholangiocarcinoma, NSCLC, mesothelioma, MPNST, Tango, Glioblastoma multiforme, pancreatic, GBM, sarcoma
- Medical subject headings
- Cholangiocarcinoma, Mesothelioma, Neurofibrosarcoma, Glioblastoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNG908Drug
TNG908, a selective PRMT5 inhibitor, will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD Receives: Drug: TNG908 |
| Dose Expansion in NSCLC | Experimental | Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
| Dose Expansion in Mesothelioma | Experimental | Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
| Dose Expansion in Pancreatic Ductal Adenocarcinoma | Experimental | Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
| Dose Expansion in Sarcoma | Experimental | Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
| Dose Expansion in solid tumors | Experimental | Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
| Dose Expansion in Glioblastoma | Experimental | Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D Receives: Drug: TNG908 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1:
To determine the MTD and dosing schedule of TNG908
Measured: 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
Measured: 16 weeks
Secondary outcomes (9)
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
Measured: 16 weeks
Phase 1 and 2:
To describe the safety and tolerability profile of TNG908 by frequency and severity of AEs
Measured: 28 days
Phase 1 and 2:
Area under the plasma concentration versus time curve (AUC)
Measured: 16 days
Phase 1 and 2:
Time to achieve maximal plasma concentration (Tmax)
Measured: 16 days
Phase 1 and 2:
Maximum observed plasma concentration (Cmax)
Measured: 16 days
Phase 1 and 2:
Terminal elimination half-life (t1/2)
Measured: 16 days
Phase 1 and 2:
Apparent total plasma clearance when dosed orally (CL/F)
Measured: 16 days
Phase 1 and 2:
Apparent volume of distribution when dosed orally (Vz/F)
Measured: 16 days
Phase 1 and 2:
SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG908
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start23 Mar 2022
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: Sponsor Decision - Business Decisions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 6 arms (parallel)
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tango Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maxim Pimkin, MD, PhD, Study director, Tango Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275478
- Sponsor's protocol ID
- TNG908-C101
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05275478
- Acronym / sponsor ID
- TNG908-C101
- Conditions
- Locally Advanced Solid Tumor
- Keywords
- MTAP deletion, PRMT5, cholangiocarcinoma, NSCLC, mesothelioma, MPNST, Tango, Glioblastoma multiforme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - Business Decisions
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tango Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Phase 1 dose escalation (sequential) followed by phase 2 dose expansion in 6 arms (parallel)
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: TNG908Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD |
| Dose Expansion in NSCLC | Experimental | Drug: TNG908Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D |
| Dose Expansion in Mesothelioma | Experimental | Drug: TNG908Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D |
| Dose Expansion in Pancreatic Ductal Adenocarcinoma | Experimental | Drug: TNG908Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D |
| Dose Expansion in Sarcoma | Experimental | Drug: TNG908Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D |
| Dose Expansion in solid tumors | Experimental | Drug: TNG908Participants with other MTAP-deleted solid tumors will receive TNG908 at the identified RP2D |
| Dose Expansion in Glioblastoma | Experimental | Drug: TNG908Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNG908TNG908, a selective PRMT5 inhibitor, will be administered orally | Drug | Dose Escalation, Dose Expansion in Glioblastoma, Dose Expansion in Mesothelioma, Dose Expansion in NSCLC, Dose Expansion in Pancreatic Ductal Adenocarcinoma, Dose Expansion in Sarcoma, Dose Expansion in solid tumors |
Primary outcome
Phase 1:
Time frame: 28 days
To determine the MTD and dosing schedule of TNG908
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
9 secondary outcomes
Phase 1:
Time frame: 16 weeks
Phase 1 and 2:
Time frame: 28 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 16 days
Phase 1 and 2:
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Sponsor Decision - Business Decisions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 39756156Briggs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxim Pimkin, MD, PhD study director
Tango Therapeutics, Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNG908 in people with Locally Advanced Solid Tumor, run by Tango Therapeutics, Inc. at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision - Business Decisions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.