NCT00105170TerminatedPhase 1
A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Biogen
- Enrollment
- 13
- Locations
- 4
- Primary Endpoint
- To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Time Frame: up to 2 years
Secondary Outcomes
- To define the recommended Phase II dose of hCBE-11(up to 2 years)
Investigators
Study Sites (4)
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