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

Biogen

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: BIIB022

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555724

212ST101

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

BIIB022

Experimental group

Treatment:

Drug: BIIB022