NCT05870579 - [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 13, 2023

Primary Completion Date

December 30, 2026

Study Completion Date

January 26, 2032

Conditions

Breast Cancer

Interventions

DRUG

[68Ga]Ga-NeoB

"\[68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions, at screening, potentially at Cycle 2 Day 15 visit, and between 4 and 8 weeks after the last administered dose of \[177Lu\]Lu-NeoB.~\[68Ga\]Ga-NeoB will be administered as a single intravenous (i.v.) dose."

DRUG

[177Lu]Lu-NeoB

Study participants will receive \[177Lu\]Lu-NeoB once every cycle

DRUG

Ribociclib

600 mg once daily (OD) days 1 to 21 every 28 days

DRUG

Fulvestrant

500 mg at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and every 28 days thereafter

OTHER

Goserelin

For pre/peri-menopausal women and men only.

Trial Locations (25)

19104

RECRUITING

University of Pennsylvania, Philadelphia

28034

RECRUITING

Novartis Investigative Site, Madrid

28040

RECRUITING

Novartis Investigative Site, Madrid

33076

RECRUITING

Novartis Investigative Site, Bordeaux

44805

RECRUITING

Novartis Investigative Site, Saint-Herblain

45147

RECRUITING

Novartis Investigative Site, Essen

50937

RECRUITING

Novartis Investigative Site, Cologne

63011

RECRUITING

Novartis Investigative Site, Clermont-Ferrand

66205

RECRUITING

University of Kansas Medical Center, Westwood

67200

RECRUITING

Novartis Investigative Site, Strasbourg

77030

RECRUITING

MD Anderson Cancer Center, Houston

80377

RECRUITING

Novartis Investigative Site, München

84107

RECRUITING

Utah Intermountain Medical Center, Murray

90095

RECRUITING

UCLA Jonsson Comp Cancer Center, Los Angeles

91054

RECRUITING

Novartis Investigative Site, Erlangen

92210

RECRUITING

Novartis Investigative Site, Saint-Cloud

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

200032

RECRUITING

Novartis Investigative Site, Shanghai

300308

RECRUITING

Novartis Investigative Site, Tianjin

510060

RECRUITING

Novartis Investigative Site, Guangzhou

44-102

RECRUITING

Novartis Investigative Site, Gliwice

4200-072

RECRUITING

Novartis Investigative Site, Porto

08907

RECRUITING

Novartis Investigative Site, L'Hospitalet de Llobregat

08035

RECRUITING

Novartis Investigative Site, Barcelona

08036

RECRUITING

Novartis Investigative Site, Barcelona