CAAA603D12101: [177Lu] Lu-NeoB in combination with Capecitabine
Research type
Research Study
Full title
A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with CDK4/6 inhibitor
IRAS ID
1009808
Contact name
Maria Topizopoulou
Contact email
Sponsor organisation
Novartis Pharma AG
ISRCTN Number
ISRCTN15516131
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is determining the safest and most appropriate dose and dosing schedule of Lutetium-NeoB in combination with capecitabine in participants with your type of breast cancer. This study will be divided into two parts:
• Phase I- Dose Escalation
The dose of the test drug is increased a little at a time in different groups of people until the recommended dose for the next part of the study is found, based on the side effects that patients experience. A dose escalation study may also measure ways that the drug is used by the body.
• Phase II- Dose Optimisation
This part explores the doses identified in part I more, to see if they work against breast cancer and to look more at safety and tolerability.
This study will also explore the safety of the PET imaging agent, Gallium-NeoB, and how well this identifies the GRPR protein that may be found on your breast cancer cells. About 18 participants will be included in phase I (escalation) and 28-40 participants will be included in phase II (expansion), from about 13 countries.
The study treatment will comprise of two medicines: Lutetium-NeoB is an investigational type of cancer treatment called radioligand therapy (RLT), which delivers targeted radiation to cancer cells (and minimises radiation to healthy tissue) by binding to the GRPR receptor on the cell surface. The treatment is delivered via a cannula inserted into a vein in your arm and the drug travels through the bloodstream to tumour cells. This typically takes 10 minutes to complete. The second study medicine is Capecitabine, which is already an approved medicine for breast cancer. Participants will be in the study for about 6 years (1 year on treatment and 5 years of follow-up). During this time, participants will undergo a variety of tests and procedures. Participants may experience unanticipated side effects from the study treatments and/or procedures done in this trial. The study doctor will keep a close eye on any side effects.REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0511
Date of REC Opinion
10 Sep 2024
REC opinion
Further Information Favourable Opinion