Table of Contents
- Trial overview
- Study design and phase
- Who can participate
- What is being measured
- Why biodistribution matters
- Trial status and size
Trial overview
The available clinical trial is a first-in-human study of [177Lu]Lu-ABY-271 in subjects with HER2-positive metastatic breast cancer.[1] It is designed to look at safety, tolerability, and biodistribution, which means how the study drug moves through the body and where it goes in tumors and critical organs.[1]
The trial is authorised and is listed as an interventional study, meaning researchers give the study treatment and then measure the effects.[1]
Study design and phase
This is a Phase 1 trial, which is an early stage of research mainly focused on safety and tolerability in people.[1] The study is described as open-label, two-stage, and randomized.[1]
Open-label means everyone in the study knows what treatment is being given.[1] Randomized means participants are assigned by chance to study groups, which helps compare results more fairly.[1]
The trial summary says Part A and Part B both evaluate safety and tolerability after a single intravenous infusion of [177Lu]Lu-ABY-271.[1]
Who can participate
The trial is for subjects with HER2-positive metastatic breast cancer.[1] This means the cancer must be breast cancer that has spread to other parts of the body and must have the HER2 feature.[1]
The source does not provide more detailed eligibility rules, such as age limits, prior treatments, or other health requirements.[1]
What is being measured
The main outcomes include treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities.[1] These are ways to track unwanted health problems after the study treatment starts.[1]
The study also measures changes in safety laboratory parameters, vital signs, echocardiogram results, and 12-lead ECG results.[1] These tests help researchers see whether the treatment affects the blood, the heart, or other body systems.[1]
Because the trial is in an early phase, these safety measures are central to understanding whether the treatment can be studied further.[1]
Why biodistribution matters
Biodistribution is an important part of this study because it shows where [177Lu]Lu-ABY-271 goes after it is given by vein.[1] The trial specifically looks at tumors and critical organs, which helps researchers understand whether the study drug reaches the intended areas and how it spreads in the body.[1]
This information is especially important in a first-in-human trial, because it helps build early knowledge about how the treatment behaves in people with cancer.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 21 participants.[1]
With a small enrollment and a Phase 1 design, this study is focused on early research questions rather than proving long-term benefit.[1]
