Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer

StatusCompleted
PhasePhase 1
SponsorMark Stein
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Jul 2026 to Apr 10, 2025
    • Eligibility criteria expanded, about 33 words
  2. Primary completion date: Sep 2024 to Jul 2026v3 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 21 to confirmed 8
    • Study completion date: Sep 2026 to Jul 2028
    • Site details revised
  3. Primary completion date: Sep 2022 to Sep 2024v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Sep 2024 to Sep 2026
    • Eligibility criteria expanded, about 364 words
    • Study description expanded, about 3 words
  4. Study First Submitted
  • 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.
Primary Objective: \- To evaluate the safety and tolerability of ADXS-504 and to determine the MTD (maximum tolerated dose) or RP2D (recommended phase two dose) Secondary Objectives: * To characterize the immunological activity of ADXS-504, administered as; and to characterize the genomic profiles of study subjects * To evaluate the effects of ADXS-504 on change in PSA * To evaluate time to PSA progression
Trial Details
NCT Number NCT05077098
Lead Sponsor Mark Stein
Conditions
(from sponsor)		 Recurrent Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov