Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer

NCT05077098 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AAAT0847
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer Type Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)

  To determine safety and tolerability profile of ADXS-504 of the investigational product

  28 days

Study Arms (1)

ADXS-504 Monotherapy Dose Escalation

EXPERIMENTAL

Subjects with Biochemically Recurrent Prostate Cancer will receive ADXS-504 with dose escalation schema.

Drug: ADXS-504

Interventions

ADXS-504 DRUG

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.

Also known as: ADXS-504 immunotherapy

ADXS-504 Monotherapy Dose Escalation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
• Age ≥18 years
• Previously undergone primary therapy for prostate cancer. Salvage XRT or cryotherapy following primary therapy ≥ 6 months prior to randomization is allowed.
• A rising prostate specific antigen (PSA) defined as the following
• If the subject's primary therapy was radical prostatectomy (RP) (with or without adjuvant or salvage XRT), rising PSA is defined as 2 consecutive rising values above 0.1 ng/mL, each taken ≥ 3 weeks apart, and the last value ≥ 0.3 ng/mL
• If the subject received other primary therapies (e.g. XRT, cryosurgery, brachytherapy), rising prostate specific antigen (PSA) is defined per the Phoenix definition, i.e., 2 consecutive rising values above the PSA nadir plus 2.0 ng/mL.
• PSA ≥0.3 in addition to prostate-specific antigen doubling time (PSADT)≥4 months. PSADT will be determined from all non-zero PSA values within 12 months prior to registration. To calculate PSADT, there must be at least THREE PSA values, with at least 3 weeks between each measurement. The PSADT will be computed from the formula: PSADT = (loge2)/k, with k being the estimated slope of the logarithm of PSA over time.
• The following web site may also be used:
• http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70%
• Testosterone ≥ 150 ng/dL ≤ 28 days of prior to registration
• Adequate bone marrow, hepatic, and renal function.
• Subject has baseline blood oxygen saturation on room air of ≥95%;
• Subject has the ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
• Subject is willing and able to provide an archived biopsy specimen which may be used for correlative studies and to determine human leukocyte antigen(HLA) type;

You may not qualify if:

• Medical Conditions
• Subject has evidence of measurable or evaluable metastatic disease on bone or computed tomography (CT) or positron emission tomography(PET) scans performed ≤8 weeks of registration (patients with PET scan findings consistent with metastasis but who have normal conventional imaging by CT/MRI/Bone scan using standard radiographic criteria ARE eligible)
• Subject has known brain metastasis. Subjects with neurological symptoms must undergo a CT scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis;
• Subject has an active autoimmune disease requiring systemic treatment within the past 3 months, a documented history of clinically severe autoimmune disease, or a disorder that requires systemic corticosteroids or immunosuppressive agents. Subjects with vitiligo, psoriasis, alopecia or resolved childhood asthma/atopy not requiring systemic treatment would be an exception to this rule. Subjects with hypothyroidism who are stable on hormone replacement (\>10 mg daily prednisone equivalent) or Sjögren's syndrome will not be excluded from the study;
• Subject has had an allogeneic tissue/solid organ transplant;
• Subject has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies);
• Subject has a known active hepatitis B (e.g., hepatitis B virus surface antigen reactive) or hepatitis C infection (e.g., hepatitis C virus RNA \[qualitative\] is detected);
• Subject has an active infection requiring systemic therapy or is dependent on or currently receiving antibiotics that cannot be discontinued before dosing. (Note: Subjects who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any study treatment);
• Subject has an implanted medical device that poses a high risk for bacterial colonization and/or that cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screws, metal plates, bone grafts, or other exogenous implants). NOTE: More common devices and prosthetics that include arterial and venous stents, dental and breast implants and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device or implant;
• Subject has a contraindication (e.g., sensitivity/allergy) to trimethoprim/ sulfamethoxazole; ampicillin; ciprofloxacin
• Subject has a contraindication to NSAIDs;
• Subject has a known allergy to any component of the study formulation(s);
• Subject has a history of listeriosis;
• Subject has had a major surgery, open biopsy or significant traumatic injury ≤6 weeks of registration;
• Subject has any other serious or uncontrolled physical or mental condition/disease that, as judged by the Investigator, could place the subject at higher risk derived from their participation in the study, could confound results of the study, or would be likely to prevent compliance with the requirements of the study.

Sponsors & Collaborators

• Mark Stein: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark N. Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 14, 2021
• Study Start: August 12, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)