Clinical Trial

S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.
Protocol Amendment History 5 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-27
notable Enrollment reduced: 342 -> 60 participants 2026-05-27
notable Trial sites reduced: 35 -> 22 locations 2026-05-27
notable Primary completion moved earlier: 2031-10-31 -> 2027-05-01 2026-05-27
minor Completion moved earlier: 2031-10-31 -> 2027-05-01 2026-05-27
Trial Details
NCT Number NCT06188702
Lead Sponsor Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Internationales Servier, Tango Therapeutics, Inc.
Conditions MTAP-deleted Solid Tumors
Enrollment 60 participants
Start Date 2024-04-29
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-26