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.
- Conditions
- CEA positieve solide tumorenadvanced and/or metastatic CEA positieve solide tumors/organ tumors10027655
- Registration Number
- NL-OMON41678
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
*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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* to describe the safety profile for qW, q2W and q3W regimens.<br /><br>* to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)<br /><br>* to describe the pharmacokinetics (PK) of single-agent RO6895882.<br /><br><br /><br>Substudy BP28920/IMG<br /><br>To investigate the in vivo biodistribution and organ pharmacokinetics of<br /><br>radioactivity (89Zr) at two doses: 6 mg (or a lower dose should 6 mg not be<br /><br>considered safe in Part I of the main study BP28920) and at the maximum<br /><br>tolerated dose (MTD) or a lower dose with equivalent pharmacodynamic (PD)<br /><br>effects as determined for the q2W regimen in Part II of the main study BP28920.<br /><br><br /><br>Substudy BP28920/ obinutuzumab:<br /><br>Proportion of patients without ADA titer at Cycle 4<br /><br>To evaluate the safety and tolerability of administration of obinutuzumab given<br /><br>prior<br /><br>to treatment with RO6895882</p><br>
- Secondary Outcome Measures
Name Time Method