Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RG1507 | Drug | Teprotumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: RG1507
Primary outcomes (1)
- measure
- Percent reduction in IGF-1R expression
- timeFrame
- From initial diagnosis to tumor excision
Secondary outcomes (2)
- measure
- Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
- timeFrame
- Days 1, 8 and 31
- measure
- Adverse events, laboratory parameters
- timeFrame
- Throughout study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available