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Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC

Study acronym: GPC3
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 42 words Site details revised at 7 of 13 sites Show 1 more changeShow less
    • Site details revised at 7 of 13 sites
  2. Notable Phase: Phase 1 to Phase 1/2 Enrollment target: 70 to 590 · Primary completion date: Mar 2029 to Jun 2030 · Start date: Nov 15, 2024 to Sep 5, 2025 · 6 morev3 Show 9 more changesShow less
    • Enrollment target: 70 to 590
    • Primary completion date: Mar 2029 to Jun 2030
    • Start date: Nov 15, 2024 to Sep 5, 2025
    • Primary endpoints: 4 to 5
    • Study sites: 2 to 13
    • Completion date: Jan 2031 to Jun 2031
    • Eligibility criteria expanded, about 33 words
    • Study arms: 1 to 2
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 1 to 2 Start date changed from estimate of Dec 2024 to Nov 15, 2024v2 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2024 to Nov 15, 2024
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
1,512 trials monitored
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Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
Trial Details
NCT Number NCT06726161
Lead Sponsor RayzeBio, Inc.
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 590 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov