A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC

Prior treatment

• Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer.
• Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment.
• Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment.
• Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
• Concurrent serious (as determined by the Investigator) medical conditions.

Other illness

• Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
• Known hypersensitivity to the components of the study therapy or its analogs.
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

Other

• Any FDG-positive and PSMA-negative target lesions.
• A superscan as seen in the baseline bone scan.

• Participants must have the ability to understand and sign ICF.
• Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
• Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.
• Participant must have been diagnosed with mCRPC with documented progressive disease.
• Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
• Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool.
• Participants with an ECOG performance status of 0 - 2.
• Participants must have adequate organ function
• For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration.