Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

Exclusion Criteria19

• 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.
• Known history of haematological malignancy.
• Known history of central nervous system (CNS) metastases.
• Histological findings consistent with neuroendocrine phenotype of prostate cancer.
• Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment.
• Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy.
• Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.
• Ongoing treatment with bisphosphonates for bone-targeted therapy.
• Severe urinary incontinence that would preclude safe disposal of radioactive urine.
• Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.
• Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.
• Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.
• Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.
• Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and/or dosimetry calculations.
• Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.
• Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and/or during study participation.