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Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial sites expanded: 65 → 80 locationsv13
  2. Site contacts updated at 1 of 65 sitesv12
  3. Study sites: 58 to 65v11
  4. Study sites: 53 to 58v10
  5. Study sites: 50 to 53v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 46 to 50v8
  2. Study sites: 45 to 46
    • Study description expanded, about 97 words
    v7
  3. Enrollment target: 200 to 325v6 Show 5 more changesShow less
    • Primary endpoints: 3 to 6
    • Study sites: 43 to 45
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 3 to 5
    • Study arms: 4 to 7
  4. Study sites: 37 to 43v5
  5. Enrollment target: 50 to 200v4 Show 8 more changesShow less
    • Primary endpoints: 1 to 3
    • Study sites: 28 to 37
    • Interventions: Cretostimogene Grenadenorepvec (Drug), n-dodecyl-B-D-maltoside (Drug) to Cretostimogene Grenadenorepvec (Drug)
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 86 words
    • Study arms: 2 to 4
    • Study title shortened, about 2 words
  6. Study sites: 3 to 28v3
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 3
    • Interventions: Cretostimogene Grenadenorepvec (Drug) to Cretostimogene Grenadenorepvec (Drug), n-dodecyl-B-D-maltoside (Drug)
    • Eligibility criteria shortened, about 351 words
    • Study description expanded, about 68 words
    • Study title expanded, about 3 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
Trial Details
NCT Number NCT06567743
Lead Sponsor CG Oncology, Inc.
Conditions
(from sponsor)		 High-Risk Non-Muscle-Invasive Bladder Cancer
Related terms Urinary Bladder Neoplasms
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov