drugset / Trial / NCT05870579

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

NCT05870579

Phase 1 Active not recruiting 28 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
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

Indications