Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

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

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Age 18 years or older at the time of informed consent

• Relapsed or refractory solid tumors following standard therapy.

• ECOG Performance Status 0 or 1.

Exclusion Criteria:

• History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening.

• History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.

• Known central nervous system or brain metastases.

• Prior anti-IGF-1R therapy of any kind.

Other protocol-defined inclusion/exclusion criteria may apply.