To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.
Serum testosterone levels <50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
Presence of disease target or non target lesions (per RECIST v1.1) on CT/MRI and/or presence of disease on full body 99mTc bone scan performed within 28 days of screening.
Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.
Presence of significant PSMA-negative disease on ceCT/MRI scan
Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).
Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.
Blue Earth Therapeutics Ltd
Lead sponsor
PSI CRO
Collaborator