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A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

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

Record History

  1. Primary and study completion pushed from Aug 2026 to Aug 2027v20
  2. Enrollment target: 38 to 48v19
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 32 to confirmed 38 · Study sites: 52 to 49 · Primary completion date: Jun 10, 2026 to Aug 2026 · 1 morev18 Show 4 more changesShow less
    • Enrollment target: estimated 32 to confirmed 38
    • Study sites: 52 to 49
    • Primary completion date: Jun 10, 2026 to Aug 2026
    • Completion date: Jun 1, 2029 to Aug 2026
  4. Site details revised at 39 of 52 sitesv17
  5. Site details revised at 4 of 52 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 49 to 52v15
  2. Site details revised at 2 of 49 sitesv14
  3. Study sites: 50 to 49v13
  4. Study sites: 40 to 50v12
  5. Site details revised at 1 of 40 sites Eligibility criteria shortened, about 2 wordsv11 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 3 of 40 sitesv10
  7. Site details revised at 3 of 40 sitesv9
  8. Study sites: 21 to 40v8
  9. Study sites: 14 to 21v7
  10. Study sites: 7 to 14v6
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 4 to 7v5 Show 1 more changeShow less
    • Study sites: 4 to 7
  12. Start date: Jun 6, 2024 to Aug 31, 2024 Study sites: 0 to 4v4 Show 1 more changeShow less
    • Study sites: 0 to 4
  13. Start date: Apr 15, 2024 to Jun 6, 2024v3
  14. Interventions: Pembrolizumab 200 mg (Drug), S095029 (Drug) to S095029 (Drug), pembrolizumab 200 mg (KEYTRUDA ®) (Drug)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will investigate the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) in combination with pembrolizumab in in microsatellite instability-high/Defective mismatch repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.
Trial Details
NCT Number NCT06116136
Lead Sponsor Servier Bio-Innovation LLC
Collaborators: Merck Sharp & Dohme LLC, Institut de Recherches Internationales Servier
Conditions MSI-H/dMMR Gastroesophageal-junction Cancer, MSI-H/dMMR Gastric Cancer
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov