TmPSMA-02 in mCRPC

Inclusion Criteria18

• Signed, written informed consent
• Adult participants ≥ 18 years of age
• Metastatic castrate-resistant prostate cancer (mCRPC)
• Castrate levels of testosterone (\<50 ng/dL) with/without the use of androgen-deprivation therapy
• Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).
• Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:
• Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis
• ALT/AST ≤ 3 x ULN
• Serum total bilirubin ≤ 1.5 mg/dL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg/dL)
• Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
• Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:
• Hemoglobin ≥ 8 g/dL
• Absolute neutrophil count ≥ 1000/μL
• Platelet count ≥ 75,000/μL
• ECOG Performance Status that is either 0 or 1.
• Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study.
• Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.