Clinical trial · Interventional
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the discontinuation of compound development, this study has been terminated.
Summary
Brief summary (as posted)
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| RG1507 | Drug | Teprotumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R1507 in Combination With Letrozole
- description
- Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
- interventionNames
- Drug: RG1507
- Drug: Letrozole
Primary outcomes (1)
- measure
- Objective Tumor Response (Part 2)
- timeFrame
- Up to 14 months
Secondary outcomes (3)
- measure
- Pharmacokinetics (PK) Profile (Part 2)
- timeFrame
- Up to 14 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * postmenopausal female patients; * stage IV or locally advanced breast cancer; * measurable disease; * letrozole failure (Part 2); * Eastern Cooperative Oncology Group (ECOG) performance status \<=2. Exclusion Criteria: * previous chemotherapy for metastatic breast cancer; * concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug; * history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix; * concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
References
Publications (0)
Data not yet available