PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. PSW-1025 (\[At-211\]PSMA-5) is an alpha-ray-emitting drug labeled with Astatine (At-211) that targets PSMA (Prostate Specific Membrane Antigen).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
PSMA (prostate specific membrane antigen)-targeted alpha therapy drug labeled with Astatine (At-211)
Osaka University Hospital
Suita, Osaka, Japan
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: until 6 months after administration
Dose Limiting Toxicity
Time frame: within 4 weeks after single administration
Number of participants with adverse events and their details
Time frame: until 6 months after administration
Blood pressure (mmHg) and heart rate (bpm)
Time frame: until 6 months after administration
Symptoms of the participants
Time frame: until 6 months after administration
Hematological tests (blood cell counts)
Time frame: until 6 months after administration
Urine tests (occult blood and urine protein)
Time frame: until 6 months after administration
Electrocorticogram
Time frame: until 6 months after administration
Prostate-Specific Antigen (PSA) (ng/ml)
Time frame: until 6 months after administration
Tumor size on CT (mm)
Time frame: until 6 months after administration
Excretion rates in urine, feces, and breath (%injected dose)
Time frame: until 24 hours after administration
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Absorbed doses in major organs (Gy)
Time frame: until 24 hours after administration