๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-23

Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer (NCT05077098)

A Phase 1 Study of ADXS-504, a Cancer Type Specific Immunotherapy, With Biochemically Recurrent Prostate Cancer

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Mark Stein

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Columbia University Irving Medical Center โ€” New York, New York

Age range: 18 Years to 99 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Columbia University Irving Medical Center โ€” New York, New York

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—