RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Sponsor: Tango Therapeutics, Inc. • ClinicalTrials.gov ID: NCT05732831

Registry updated: 2026-09-08

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Description

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, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Interventions

TNG462 (Drug)
TNG462, a selective PRMT5 inhibitor, will be administered orally
Pembrolizumab (Drug)
An anti PD-1 antibody, will be administered intravenously

Eligibility criteria

Inclusion Criteria: 1. Age: ≥18 years-of-age at the time of signature of the main study ICF 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: 1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms 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

Conditions

Locally Advanced Solid Tumor

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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