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Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer

NCT05077098 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-25

No results posted yet for this study

Summary

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

Conditions

  • Recurrent Prostate Cancer

Interventions

DRUG

ADXS-504

ADXS-504 will be administered as monotherapy at 2 dose levels. Subjects who are assigned to receive Dose Level 1 (DL1) will be administered ADXS-504 at a dose of 1×107 CFU q4 weeks (±3 days) from Week 1 to Week 21. Subjects who are assigned to receive Dose Level 2 (DL2) will be administered ADXS-504 at a dose of 1×108 CFU q4 weeks (±3 days; Week 1 to Week 21). All 3-6 subjects must be enrolled in DL1, and DL1 must be confirmed safe, before enrollment for DL2 may begin. For both dose levels, these doses are followed by maintenance dosing at each respective dose level given every 12 (q12) weeks (±3 days) for 4 doses for overall total of 10 doses of the study treatment. If DL1 is deemed to exceed the MTD, dose reduction of ADXS-504 to DL-1 (1×106 CFU) may proceed. Dose level -1, intermediate dose levels or expansion of a cohort may also be further evaluated if recommended by the Investigator and Advaxis in future amendments.

Sponsors & Collaborators

  • Mark Stein

    lead OTHER

Principal Investigators

  • Mark N. Stein, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2026-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077098 on ClinicalTrials.gov