Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors (NCT05732831) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
United States225 participantsStarted 2023-05-26
Plain-language 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. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age: ≥18 years-of-age at the time of signature of the main study ICF
✓. Performance status: ECOG Performance Score of 0 to 1
✓. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
✓. 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
✓. Adequate liver function per local labs
✓. Adequate renal function per local labs
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