Recurrent Prostate CancerPhase 1NCT05077098
Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer
A Phase 1 study testing ADXS-504 in people with Recurrent Prostate Cancer, run by Mark Stein at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- What is being tested?
- ADXS-504
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 10 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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
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- 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;
- Subject with a female partner of child-bearing potential is eligible if he agrees to follow the contraceptive guidance, provided in Appendix 5, during the treatment period and for at least 120 days after the final dose of study treatment.
Who cannot join
- 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);
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- 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.
- Subject has a second primary malignancy with greater than minimal metastatic potential that has not been in remission for greater than 3 years. Examples of tumors that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, or non-muscle invasive urothelial carcinoma.
- Prior/Concomitant Therapy
- Subject is on or has received Luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists within 6 months prior to study enrollment;
- Subject has received oral antiandrogens within 3 months prior to study enrollment;
- Subject has received agents such as 5 alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements that are known to affect PSA (PC-SPES, saw palmetto oil) within the past month;
- Prior/Concurrent Clinical Study Experience
- Subject is currently participating in or has participated in a study of an investigational agent(s) within 4 weeks of the first dose of study treatment;
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Phase 1 Study of ADXS-504, a Cancer Type Specific Immunotherapy, With Biochemically Recurrent Prostate Cancer
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
Read the detailed description
ADXS-504 is a novel Listeria monocytogenes (Lm) - based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 1) 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 2) 10 peptide antigens derived from sequence-optimized tumor associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control.
This is a phase 1 open-label study of ADXS-504 monotherapy in subjects with biochemically recurrent prostate cancer previously treated with radical prostatectomy (RP) or radiation therapy (external beam or brachytherapy) who are not currently receiving androgen ablation therapy. The purpose of this study is to evaluate safety, tolerability, and preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.
- Conditions
- Recurrent Prostate Cancer
- Being tested
- ADXS-504
- Keywords
- Cancer Type Specific Immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADXS-504Drug
Also called ADXS-504 immunotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| ADXS-504 Monotherapy Dose Escalation | Experimental | Subjects with Biochemically Recurrent Prostate Cancer will receive ADXS-504 with dose escalation schema. Receives: Drug: ADXS-504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start12 Aug 2021
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Stein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Stein, Columbia University
- Investigators
- Mark N. Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077098
- Sponsor's protocol ID
- AAAT0847
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of ADXS-504, a Cancer Type Specific Immunotherapy, With Biochemically Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT05077098
- Acronym / sponsor ID
- AAAT0847
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Cancer Type Specific Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mark SteinUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
ADXS-504 is a novel Listeria monocytogenes (Lm) - based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 1) 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 2) 10 peptide antigens derived from sequence-optimized tumor associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control.
This is a phase 1 open-label study of ADXS-504 monotherapy in subjects with biochemically recurrent prostate cancer previously treated with radical prostatectomy (RP) or radiation therapy (external beam or brachytherapy) who are not currently receiving androgen ablation therapy. The purpose of this study is to evaluate safety, tolerability, and preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADXS-504 Monotherapy Dose Escalation | Experimental | Drug: ADXS-504Subjects with Biochemically Recurrent Prostate Cancer will receive ADXS-504 with dose escalation schema. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADXS-504Also: ADXS-504 immunotherapyADXS-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. | Drug | ADXS-504 Monotherapy Dose Escalation |
Primary outcome
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)
Time frame: 28 days
To determine safety and tolerability profile of ADXS-504 of the investigational product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark N. Stein, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADXS-504 in people with Recurrent Prostate Cancer, run by Mark Stein at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.