Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)

Exclusion Criteria

• •1. BMI ≥ 30.
• •2. Evidence of brain metastasis.
• •3. Patient seropositive for HIV and/or hepatitis B antigen positive and/or Hepatitis C antibody.
• •4. Patient with history of autoimmune disease with the exception of vitiligo, psoriasis and controlled diabetes.
• •5. Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegener's granulomatosis and Hashimoto's thyroiditis).
• •6. Patient with history of another malignancy, except for the following: skin cancers (melanoma excluded), previously treated cancer with no sign of disease for at least 3 years.
• •7. Patient with concurrent infection or concurrent chronic or acute illness such as pulmonary (asthma or COPD), cardiac (NYHA class III or IV) or hepatic disease, or other illness considered by the principal investigator to constitute an unwarranted high risk for investigational drug administration will be excluded.
• •8. Patient who has got a medical condition contraindicated for subcutaneous administration.
• •9. Chronic systemic corticosteroid use within 4 weeks of the first administration of SXL01 (more than 2 weeks for a dose \> 0.5 mg/kg of prednisolone).
• •10. Treatment with any hormonal therapy or androgen antagonist, including flutamide, bicalutamide, nilutamide, ketoconazole, diethylstilbestrol, Abiraterone, or enzalutamide, within 4 weeks of the first administration with the exception of GnRH agonists.
• •11. Patients requiring a continuous curative anti-coagulant treatment.
• •12. Patients requiring a continuous bisphosphonate or denosumab treatment at inclusion. Note: the use of bisphosphonate and denosumab during the course of the study will be allowed.
• •13. Planned to initiate any other anti-tumor therapies during the study.
• •14. Radiation therapy or surgery within 4 weeks of the first administration of SXL01.
• •15. Mental impairment (psychiatric illness/social situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study.
• •16. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.