Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker

Exclusion Criteria

• •1. Other malignancy requiring active therapy
• •2. Non-measurable tumor disease
• •3. Patients with active brain metastases (patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks, after consultation with the sponsor, are not excluded from the trial)
• •4. Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication
• •5. Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all
• •6. Other investigational drug within the past 4 weeks before start of trial medication
• •7. Patients undergoing renal dialysis
• •8. Pulmonary disease with clinical relevant hypoxia
• •9. Evidence of active, non-infectious pneumonitis or history of interstitial lung disease
• •10. Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease
• •11. Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months
• •12. Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease
• •13. Renal outflow obstruction, macroscopic or significant microscopic hematuria
• •14. Active infectious diseases considered by investigator to be incompatible with protocol
• •15. Major surgery within 28 days
• •16. Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants
• •17. Pregnant or breastfeeding women
• •18. Psychiatric disorders, drug and/or alcohol abuse
• •19. Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
• •20. Known hypersensitivity to GEM3PSCA excipients
• •21. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
• •22. Incapability of understanding purpose and possible consequences of the trial
• •23. Patients who should not be included according to the opinion of the investigator