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

A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555724

Enrollment

Registered

2007-11-09

Start date

2008-01-31

Completion date

2010-07-31

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Relapsed, refractory, solid tumor

Brief summary

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

Interventions

DRUGBIIB022

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of BIIB022	ongoing

Secondary

Measure	Time frame
To evaluate pharmacokinetics	ongoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026