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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 22 to 20v15
  2. Enrollment reduced: 342 → 60 participants Primary and study completion moved earlier from Oct 31, 2031 to May 1, 2027 · Trial status changed: Recruiting → Active, Not Recruiting · Trial sites reduced: 35 → 22 locationsv14 Show 3 more changesShow less
    • Primary and study completion moved earlier from Oct 31, 2031 to May 1, 2027
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 35 → 22 locations
  3. Site details revised at 5 of 35 sitesv13
  4. Study sites: 33 to 35v12
  5. Enrollment target: 308 to 342 Eligibility criteria expanded, about 174 words · Site details revised at 2 of 33 sitesv11 Show 2 more changesShow less
    • Eligibility criteria expanded, about 174 words
    • Site details revised at 2 of 33 sites

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 32 to 33v10
  2. Study sites: 33 to 32v9
  3. Phase: Phase 1 to Phase 1/2 Enrollment target: 27 to 308 · Primary and study completion dates: May 1, 2026 to Oct 31, 2031 · Primary endpoints: 3 to 4 · 7 morev8 Show 10 more changesShow less
    • Enrollment target: 27 to 308
    • Primary and study completion dates: May 1, 2026 to Oct 31, 2031
    • Primary endpoints: 3 to 4
    • Study sites: 11 to 33
    • Interventions: S095035 (Drug) to S095035 (Drug), TNG462 (Drug)
    • Eligibility criteria expanded, about 486 words
    • Secondary endpoints: 14 to 22
    • Collaborators: 1 to 2
    • Study arms: 1 to 9
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 5 of 11 sitesv7
  5. Study sites: 6 to 11v6
  6. Study sites: 5 to 6v5
  7. Site details revised at 1 of 5 sitesv4
  8. Site details revised at 1 of 5 sitesv3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of Mar 2024 to Apr 29, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Mar 2024 to Apr 29, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov