UnknownCancerNIHR-supported projectDigestion, Kidneys & Other Organs
CAAA603D12101: A Phase I, 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 a CDK4/6 inhibitor.
Recipient organisationNIHR Imperial Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodApr 2025 — Ongoing
In plain English
AI plain-English summary
A clinical trial is testing whether pairing a targeted radioactive drug with an existing chemotherapy pill can shrink a hard-to-treat form of breast cancer. The cancer in question is estrogen receptor-positive, HER2-negative metastatic breast cancer that has stopped responding to standard hormone therapy combined with a CDK4/6 inhibitor. Once those treatments fail, options are limited. The experimental drug, Lutetium-NeoB, is a radioligand therapy that delivers radiation directly to cancer cells by latching onto a protein called GRPR on their surface, while largely sparing healthy tissue. The chemotherapy drug capecitabine is already approved for breast cancer. If the trial finds a safe and effective dose and schedule, this combination could offer a new treatment line for patients who have run out of standard options. The approach is not a cure, but it could extend the time the cancer is controlled and delay the need for more toxic therapies. The study also tests whether a companion imaging agent, Gallium-NeoB, can reliably detect GRPR-positive tumours, which could help select patients most likely to benefit from this targeted therapy in future.
View original technical description
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.
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