Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
NCT ID: NCT05275478
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
192 participants
INTERVENTIONAL
2022-03-23
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose 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
Dose 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
Dose 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
Dose 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
Dose 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
Dose 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
Dose 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
Interventions
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TNG908
TNG908, a selective PRMT5 inhibitor, will be administered orally
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Tango Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maxim Pimkin, MD, PhD
Role: STUDY_DIRECTOR
Tango Therapeutics, Inc.
Locations
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University of California Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States
Northwestern University
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
EDOG Institut de Cancerologie de l'Ouest
Saint-Herblain, , France
Institut Oncopole Claudius Regaud
Toulouse, , France
Institute Gustav Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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TNG908-C101
Identifier Type: -
Identifier Source: org_study_id