A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882674

Enrollment

Registered

2009-04-16

Start date

2009-07-31

Completion date

2010-12-31

Last updated

2016-11-02

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

Conditions

Breast Cancer

Brief summary

This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is \< 3 months, and the target sample size is \<100 individuals.

Interventions

DRUGRG1507

16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* female patients, \>=18 years of age; * invasive, and operable, breast cancer; * ECOG Performance Status of 0 or 1.

Exclusion criteria

* evidence of metastatic disease; * inflammatory breast cancer; * prior hormonal or systemic therapy for breast cancer; * prior treatment with an agent targetting the IGF-1R pathway; * patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.

Design outcomes

Primary

Measure	Time frame
Percent reduction in IGF-1R expression	From initial diagnosis to tumor excision

Secondary

Measure	Time frame
Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue	Days 1, 8 and 31
Adverse events, laboratory parameters	Throughout study

Countries

United Kingdom

Outcome results

None listed

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