Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Relapsed or refractory solid tumors not curable with standard therapy.

• At least one measurable lesion

• ECOG Performance Status less than or equal to 2

• Acceptable hematologic status

• Albumin greater than or equal to 2.5 g/dL

• Normal calculated glomerular filtration rate (GFR)

• Acceptable liver function

Exclusion Criteria:

• Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day

• Known history of hepatitis B or C, or HIV infection

• Clinically significant effusions, including pericardial, pleural, and ascites

• Serious non-malignant disease

• Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated

• Investigational therapies within 4 weeks of Study Day 1

• Radiation therapy of tumors to be followed for this study

• Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1

• Current Grade 3 or 4 neurological toxicity

• Concurrent anti-neoplastic therapy and/or steroids