drugset / Trial / NCT05870579
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease.
Timeline
- Start
- 2023-11-13
- Primary completion
- 2026-12-30
- Completion
- 2032-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [177Lu]Lu-NeoB | Other / unclassified | 3700 mbq | — |
| Subject | [177Lu]Lu-NeoB | Other / unclassified | 5550 mbq | — |
| Subject | [177Lu]Lu-NeoB | Other / unclassified | 7400 mbq | — |
| Subject | [177Lu]Lu-NeoB | Other / unclassified | 9250 mbq | — |
| Background | Fulvestrant | Small molecule | 500 mg | — |
| Background | Ribociclib | Small molecule | 600 mg | — |