Phase I Trial of 225Ac-J591 in Patients With mCRPC

Exclusion Criteria

• •1. Implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current enrollment in oncologic investigational drug or device study
• •2. Use of investigational drugs ≤4 weeks or \<5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
• •3. Prior systemic beta-emitting bone-seeking radioisotopes
• •4. Known active brain metastases or leptomeningeal disease
• •5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
• •6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
• •7. Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
• •8. Patients on stable dose of bisphosphonates or Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study.
• •9. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
• •10. Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.
• •11. Known history of known myelodysplastic syndrome