Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

Exclusion Criteria

• •1. Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
• •2. Tumors of borderline malignancy
• •3. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
• •4. Pregnant or lactating (nursing) women
• •5. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever \>38.0 ⁰C associated with a clinical diagnosis of active infection
• •6. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
• •7. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment
• •8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment
• •9. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
• •10. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
• •11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP
• •12. In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent
• •13. Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS
• •14. Known hypersensitivity to any of the excipients in the study drug
• •15. Persons who have been placed in an institution under an official or judicial order
• •16. Persons who are dependent on the sponsor financially must be excluded from participation
• •17. Persons with active SARS-CoV-2 infection must be excluded from participation