[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2-, GRPR+ Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2030-12-31

Summary

The purpose of this phase 1b, single arm, multicenter, open label, dose finding study is to estimate the RD of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in adult female participants with ER+, HER2-, GRPR+, advanced or metastatic breast cancer who have relapsed during or within 12 months from completion of prior (neo)adjuvant ET (escalation part). Additionally this study aims to characterize the safety and tolerability of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in post-menopausal participants and in combination with ribociclib, fulvestrant and goserelin in pre/peri-menopausal participants (expansion part) in the same indications.

• Phase: Phase 1

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fulvestrant; Goserelin