Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
NCT ID: NCT05732831
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
225 participants
INTERVENTIONAL
2023-05-26
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation
Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 single agent and in combination with pembrolizumab to estimate the MTD
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Pembrolizumab
An anti PD-1 antibody, will be administered intravenously
Dose Expansion in NSCLC
Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Dose Expansion in Mesothelioma
Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Dose Expansion in Pancreatic Ductal Adenocarcinoma
Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Dose Expansion in Sarcoma
Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Dose Expansion in Solid Tumors
Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Dose Expansion in NSCLC in Combination with Pembrolizumab
Participants NSCLC (squamous and non squamous) MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Pembrolizumab
An anti PD-1 antibody, will be administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TNG462
TNG462, a selective PRMT5 inhibitor, will be administered orally
Pembrolizumab
An anti PD-1 antibody, will be administered intravenously
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Performance status: ECOG Performance Score of 0 to 1
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
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 TNG462
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Tango Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maeve Waldron-Lynch, MD
Role: STUDY_DIRECTOR
Tango Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Palo Alto, California, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University Chicago Medicine
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Midwestern Regional Medical Center, City of Hope Chicago
Zion, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer Center
Detroit, Michigan, United States
New York University Langone Health
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
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Next Oncology Virginia
Fairfax, Virginia, United States
CHU de Brest
Brest, , France
Centre Berard Leon
Lyon, , France
Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS
Saint-Herblain, , France
Institute Gustav Roussy
Villejuif, , France
Vall d'Hebron Barcelona Hospital
Barcelona, Catalonia, Spain
Hospital HM Nou Delfos
Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital de Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TNG462-C101
Identifier Type: -
Identifier Source: org_study_id