AN OPEN-LABEL, MULTICENTRE, DOSE-ESCALATION, PHASE I STUDY WITH AN EXPANSION PHASE, TO EVALUATE SAFETY, PHARMACOKINETICS AND THERAPEUTIC ACTIVITY OF RO6895882, AN IMMUNOCYTOKINE, CONSISTING OF A VARIANT OF INTERLEUKIN-2 (IL-2v) TARGETING CARCINOEMBRYONIC ANTIGEN (CEA) ADMINISTERED INTRAVENOUSLY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS. - CEA-IL2v / BP28920

Roche Nederland B.V.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月29日

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•*Signed informed consent.
•*Confirmed advanced and/or metastatic solid tumor, with confirmed progression at baseline, for whom no standard treatment is available.
•*Radiologically measurable and clinically evaluable disease.
•*Adequate hematological function: neutrophil count of * 1.5 x 109 cells/L, platelet count of * 100,000/µl, Hb * 10 g/dL (6.2 mmol/L), including lymphocytes within normal limits.
•*Adequate liver function: Total Bilirubin * 1.5 x ULN (excluding Gilbert*s Syndrome, see below), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) * 2.5 x ULN (in case of liver metastases: * 5 x ULN).
•*Adequate renal function: serum creatinine * 1.5 ULN or creatinine clearance by Cockcroft Gault formula [see Appendix X] * 50 mL/min for patients in whom, in the investigator*s judgment, serum creatinine levels do not adequately reflect renal function.
•*Locally confirmed CEA expression in tumor tissue (>20% of tumor cells staining with at least moderate intensity);Extra for Imaging substudy:
•At least one non-liver tumor lesion that is assessable by PET imaging

•*History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening .
•*Patients with a second malignancy in the last 5 years (with the exception of basal cell carcinoma).
•*Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases. ;Extra for Imaging substudy:
•Patients who have had a hypersenitivity reaction to 2-[18F]Fluoro-2-deoxyglucose (FDG)

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