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Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

Study acronym: HyPeR
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 12, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v12
  2. Enrollment target: 34 to 60
    • Publications: details revised at 1 of 1 entry
    v11
  3. Publications: details revised at 1 of 1 entryv10
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v9
  5. Primary and study completion dates: Sep 2024 to Sep 2026v8 Show 7 more changesShow less
    • Interventions: Guadecitabine (Drug), Pembrolizumab (Drug) to ASTX727 (Drug), Guadecitabine (Drug), Pembrolizumab (Drug)
    • Eligibility criteria expanded, about 174 words
    • Study description shortened, about 67 words
    • Study sites revised (2)
    • Publications: details revised at 1 of 1 entry
    • Study title revised
    • Study arms: 2 to 3
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Jun 2021 to Sep 2024v7
  2. Primary and study completion dates: Jun 2020 to Jun 2021v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 35 to confirmed 34
    • Primary and study completion dates: Dec 2019 to Jun 2020
    • Site details revised at 2 of 2 sites
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 2018 to Dec 2019
    • Study sites: 0 to 2
    • Study completion date: Dec 2019
    • Start date: Dec 2016 to Jan 26, 2017
  6. Secondary endpoints: details revised at 2 of 7 entries
    • Study description expanded, about 7 words
    • Eligibility criteria expanded, about 3 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.
Trial Details
NCT Number NCT02998567
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: Astex Pharmaceuticals, Inc., Merck Sharp & Dohme LLC, Institute of Cancer Research, United Kingdom
Conditions
(from sponsor)		 Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov