Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors (NCT05732831)
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (17 items).
Location: Stanford University β Palo Alto, California
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
- 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 TNG462
- Active prior or concurrent malignancy.
- 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 β₯300/ΞΌL
- Undetectable viral load
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (26 Sites)
- Stanford University β Palo Alto, California
- Grand Valley Oncology β Grand Junction, Colorado
- Florida Cancer Specialists & Research Institute β Lake Mary, Florida
- Sylvester Comprehensive Cancer Center β Miami, Florida
- University Chicago Medicine β Chicago, Illinois
- Carle Cancer Center β Urbana, Illinois
- Midwestern Regional Medical Center, City of Hope Chicago β Zion, Illinois
- Massachusetts General Hospital β Boston, Massachusetts
- Dana Farber Cancer Institute β Boston, Massachusetts
- Henry Ford Cancer Center β Detroit, Michigan
- New York University Langone Health β New York, New York
- Sarah Cannon Tennessee Oncology β Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center β Houston, Texas
- Huntsman Cancer Institute, University of Utah β Salt Lake City, Utah
- Next Oncology Virginia β Fairfax, Virginia
- CHU de Brest β Brest,
- Centre Berard Leon β Lyon,
- Institut de Cancerologie de l'Ouest - HΓ΄pital Saint Herblain - PPDS β Saint-Herblain,
- Institute Gustav Roussy β Villejuif,
- Vall d'Hebron Barcelona Hospital β Barcelona, Catalonia
- Hospital HM Nou Delfos β Barcelona,
- ICO l'Hospitalet - Hospital Duran i Reynals β Barcelona,
- Hospital Universitario Fundacion Jimenez Diaz β Madrid,
- Hospital de Sanchinarro β Madrid,
- Hospital Universitario Virgen de la Victoria β MΓ‘laga,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.