Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer (NCT05077098) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer
United States8 participantsStarted 2021-08-12
Plain-language 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
Who can participate
Age range18 Years – 99 Years
SexMALE
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Inclusion criteria
✓. 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
✓. 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.
✓. 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.
Exclusion criteria
✕. 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)
✕
What they're measuring
1
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)
. 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;