Recurrent Prostate Cancer Clinical Trial
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
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. ;
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