This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prostate cancer.
Patients will be screened within 6 weeks prior to Week 1. A total of 3 cohorts, consisting of 3 to 6 patients each, are planned to receive five to eight intradermal (ID) injections totaling 1 mL up to 1.6mL of BPX-101 at 3 doses levels for an initial 6 doses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
University of Texas Health Science Center Houston, CRU
Houston, Texas, United States
Maximum tolerated dose of BPX-101 and AP1903
To determine the maximum tolerated dose (MTD) of BPX-101 and AP1903 when administered 24 hours apart
Time frame: 1 Year
Safety and tolerability of BPX-101 and AP1903
To determine other measures of safety and tolerability of BPX-101 and AP1903 when administered 24 hours apart to patients with castrate resistant prostate cancer (CRPC).
Time frame: 1 Year
Pharmacokinetics of AP1903
To determine the pharmacokinetics of AP1903 when administered 24 hours after BPX-101
Time frame: 1 Year
Immune responses and their association with clinical outcome
To assess immune responses and their association with clinical outcome as measured by changes in levels of interferon gamma (IFN)-producing T cells, the cytotoxic T lymphocyte (CTL) response, cytokines (IFN, IL-4, IL-10), activation markers, and other markers
Time frame: 2 Years
PSA response and PSA dynamics
To assess PSA response and PSA dynamics (change in velocity, doubling time)
Time frame: 1 Year
Number of circulating tumor cells (CTC)
To assess reduction in the number of circulating tumor cells (CTC)
Time frame: 1 Year
Cancer-related pain
To assess cancer-related pain
Time frame: 1 Year
Pain medication usage
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To assess pain medication usage
Time frame: 1 Year
Preliminary efficacy of BPX-101 at the maximum tolerated dose (MTD)
To determine preliminary efficacy of BPX-101 at the maximum tolerated dose (MTD), based on tumor assessments using computed tomography (CT) or magnetic resonance imaging (MRI) and radionuclide bone scans
Time frame: 2 Years