Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors (NCT05275478) | Clinical Trial Compass
TerminatedPhase 1/2
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
Stopped: Sponsor Decision - Business Decisions
United States110 participantsStarted 2022-03-23
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, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 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 or Karnofsky performance status score ≥70.
✓. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
✓. 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 TNG908 or its excipients