177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia

Exclusion Criteria

• •1. Has primary bone marrow disorder (e.g. leukemia, myeloproliferative or myelodysplastic disorder)
• •2. Presence of iron deficiency or other hematological disorders that may cause anemia and cytopenia
• •3. Has participated in a study of an investigational agent or an investigational device within 4 weeks of the first dose of study therapy
• •4. Has received treatment with an approved systemic therapy within 2 weeks of dosing or has not yet recovered (i.e., grade ≤1 or baseline) from any acute toxicities attributed to the systemic therapy.
• •5. Has received radiation therapy or major surgery within 14 days of first administration of study drug.
• •6. Has received radiopharmaceutical agents in the past (e.g., Strontium-89, PSMA-targeted radioligand therapy)
• •7. Has received prior PSMA-targeting therapy
• •8. Another malignancy that is progressing or requires active treatment with the exception of non-melanoma skin cancer that has undergone potentially curative therapy
• •9. Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
• •10. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection; or diagnosis of immunodeficiency
• •11. Has known allergy or hypersensitivity to study drugs
• •12. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy, or investigational or anti-cancer therapy
• •13. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that, in the opinion of the investigator, would impair study participation or cooperation
• •14. No active clinically significant cardiac disease is defined as any of the following:
• •a. History or current diagnosis of ECG abnormalities indicating a significant risk of safety for participants in the study, such as i. Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bi-fascicular block, Mobitz type II and third-degree AV block) ii. History of familial long QT syndrome or known family history of Torsades de Pointes
• •15. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
• •16. Symptomatic cord compression, unstable vertebral metastasis or clinical or radiologic findings indicative of impending cord compression