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

Biogen40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

BIIB022DRUG

IV infusion once every three weeks until disease progression or unacceptable toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Research Site

Los Angeles, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of BIIB022

Time frame: ongoing

Secondary Outcomes

To evaluate pharmacokinetics

Time frame: ongoing

Data from ClinicalTrials.gov

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