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S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

Study acronym: aCCeleR8-001
StatusRecruiting
PhasePhase 1/2
SponsorShionogi
Started
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Record History

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  1. Primary and study completion dates: Apr 16, 2027 to May 31, 2028v13 Show 7 more changesShow less
    • Primary endpoints revised (7)
    • Enrollment target: 274 to 282
    • Interventions: Pembrolizumab (Drug), S-531011 (Drug) to Bevacizumab (Drug), Pembrolizumab (Drug), S-531011 (Drug)
    • Eligibility criteria expanded, about 296 words
    • Secondary endpoints: 18 to 19
    • Site details revised at 2 of 8 sites
    • Study arms: 4 to 6
  2. Study sites: 6 to 8
    • Interventions: S-531011 (Drug), pembrolizumab (Drug) to Pembrolizumab (Drug), S-531011 (Drug)
    • Eligibility criteria expanded, about 265 words
    • Secondary endpoints revised (18)
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Interventions: Pembrolizumab (Drug), S-531011 (Drug) to S-531011 (Drug), pembrolizumab (Drug)v10
  5. Collaborators expanded, about 5 wordsv9
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  1. Study sites: 3 to 6v8
  2. Lead sponsor: Shionogi Inc. to Shionogi
    • Study sites: 6 to 3
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints revised (18)
    v7
  3. Study sites: 3 to 6v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 1, 2022 to May 30, 2022
    v5
  5. Start date: Jan 31, 2022 to Apr 1, 2022v4
  6. Start date: Dec 31, 2021 to Jan 31, 2022v3
  7. Start date: Nov 12, 2021 to Dec 31, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Shionogi
45 trials monitored
See 2 trials at risk
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab. The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.
Trial Details
NCT Number NCT05101070
Lead Sponsor Shionogi
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Solid Tumors
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov