The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).
The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
IV
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
The Karmanos Cancer Institute
Detriot, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Wisconsin Madison, Carbone Cancer Center
Madison, Wisconsin, United States
Safety assessed by recording of adverse events, laboratory assessments and vital signs
Time frame: For 12 weeks during treatment period and up to 4 weeks follow up
Pharmacokinetics assessment of ASG-5ME blood levels through analysis of blood samples
Time frame: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
Incidence of anti-ASG-5ME antibody formation
Time frame: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
Incidence of tumor response (complete or partial response)
Time frame: Baseline and every 12 weeks while on study drug
Changes in prostate-specific antigen (PSA) levels
Time frame: Baseline; up to day 64 during the first 12 weeks; and if the subject continues on study drug, every 3 weeks thereafter
Changes in bone scans
Time frame: Baseline and every 12 weeks while on study drug
Changes in circulating tumor cells
Time frame: Baseline; up to day 64 during the first 12 weeks; and if the subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
Changes in cytokeratin-18 levels
Time frame: Up to day 79 and 4 weeks after the last dose of study drug
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