RecruitingPhase 1NCT05870579

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

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive 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

Sponsor

Novartis Pharmaceuticals

Enrollment

48 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — a targeted radiation therapy (lutetium-177 NeoB), a CDK4/6 inhibitor (ribociclib), and a hormone therapy (fulvestrant) — in people with advanced breast cancer that is hormone receptor-positive, HER2-negative, and also expresses a protein called GRPR (gastrin-releasing peptide receptor). **You may be eligible if...** - You are 18 or older (male or female) - You have breast cancer that is oestrogen receptor-positive (ER+) and HER2-negative, confirmed by biopsy - Your tumour expresses the GRPR protein (confirmed by imaging) - Your cancer has progressed after prior hormone therapy **You may NOT be eligible if...** - Your breast cancer is HER2-positive or ER-negative - Your tumour does not express GRPR on imaging - You have untreated or unstable brain metastases - Your kidney function is significantly reduced Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

DRUGRibociclib

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

DRUGFulvestrant

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

OTHERGoserelin

For pre/peri-menopausal women and men only.

Locations(25)

UCLA Jonsson Comp Cancer Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

University of Kansas Medical Center

Westwood, Kansas, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Utah Intermountain Medical Center

Murray, Utah, United States

Novartis Investigative Site

Guangzhou, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Saint-Cloud, Hauts De Seine, France

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Saint-Herblain, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Gliwice, Poland

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT05870579

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