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Immunotherapy

ADXS-504 Immunotherapy for Prostate Cancer

Phase 1
Recruiting
Led By Mark N. Stein, MD
Research Sponsored by Mark Stein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen
Must not have
Contraindication to specific medications
Known history of HIV infection or active hepatitis B or C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective.

Who is the study for?
Men over 18 with recurrent prostate cancer after primary therapy like surgery or radiation, not on active treatment for other cancers. They must have a stable performance status, adequate organ function, and rising PSA levels according to specific criteria. Participants need to provide consent and health information release, agree to contraceptive guidance if applicable, and cannot have brain metastases or severe autoimmune diseases.
What is being tested?
The trial is testing ADXS-504 immunotherapy in men with recurring prostate cancer. It aims to find the safest dose that patients can tolerate (MTD) or recommend for future studies (RP2D), measure immune response effects of the drug, observe changes in PSA levels, and assess time until PSA levels rise again.
What are the potential side effects?
While specific side effects are not listed here, common side effects of immunotherapies like ADXS-504 may include flu-like symptoms such as fever and chills; fatigue; pain at injection site; allergic reactions; auto-immune responses where the body attacks its own cells; digestive issues; skin rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My prostate cancer was confirmed by a biopsy or surgery.
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I am mostly active and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take certain medications due to adverse reactions.
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I have a history of HIV or active hepatitis B or C.
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I have cancer that has spread to my brain.
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I have received a transplant from a donor.
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I do not have any serious or uncontrolled health conditions.
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I have another cancer type that could spread and it's been in remission for less than 3 years.
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I have used treatments that affect my PSA levels.
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I have not had major surgery or a significant injury in the last 6 weeks.
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I am currently on medication for an infection.
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I have been treated for an autoimmune disease in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)

Side effects data

From 2023 Phase 3 trial • 1460 Patients • NCT04145219
58%
Oral pruritus
55%
Throat irritation
33%
Ear pruritus
33%
Abdominal pain upper
25%
Nasopharyngitis
21%
Lip swelling
20%
Glossodynia
19%
Nausea
17%
Taste disorder
14%
Mouth swelling
14%
Swollen tongue
13%
Diarrhoea
13%
Mouth ulceration
9%
Pharyngeal swelling
7%
Tongue ulceration
7%
Vomiting
6%
Tooth loss
5%
Pharyngitis
5%
Bronchitis
5%
COVID-19
3%
Upper respiratory tract infection
2%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
HDM SLIT-tablet (12 SQ-HDM)
Placebo SLIT-tablet

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ADXS-504 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Subjects with Biochemically Recurrent Prostate Cancer will receive ADXS-504 with dose escalation schema.

Find a Location

Who is running the clinical trial?

Mark SteinLead Sponsor
3 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Mark N. Stein, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
141 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer

Media Library

ADXS-504 (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05077098 — Phase 1
Prostate Cancer Research Study Groups: ADXS-504 Monotherapy Dose Escalation
Prostate Cancer Clinical Trial 2023: ADXS-504 Highlights & Side Effects. Trial Name: NCT05077098 — Phase 1
ADXS-504 (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077098 — Phase 1
~5 spots leftby Nov 2025
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