In short
Clinical trials are investigating ABY-271 in people with HER2-positive metastatic breast cancer. This article explains what the study is trying to learn, including safety, tolerability, and where the study drug goes in the body. It also covers who may take part, the trial phase, and the main outcomes being measured.
Key points
- Clinical trials are studying ABY-271 in people with HER2-positive metastatic breast cancer. The available trial is a Phase 1 study, which means it is an early trial focused on safety and tolerability. It is open-label, two-stage, and randomized, and it includes a single intravenous infusion of [177Lu]Lu-ABY-271. Researchers are also looking at biodistribution, or how the study drug spreads into tumors and critical organs. The main outcomes include treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, and changes in lab tests, vital signs, echocardiogram results, and ECG results.
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. 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.
The trial is authorised and is listed as an interventional study, meaning researchers give the study treatment and then measure the effects.
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. The study is described as open-label, two-stage, and randomized.
Open-label means everyone in the study knows what treatment is being given. Randomized means participants are assigned by chance to study groups, which helps compare results more fairly.
The trial summary says Part A and Part B both evaluate safety and tolerability after a single intravenous infusion of [177Lu]Lu-ABY-271.
Who can participate
The trial is for subjects with HER2-positive metastatic breast cancer. This means the cancer must be breast cancer that has spread to other parts of the body and must have the HER2 feature.
The source does not provide more detailed eligibility rules, such as age limits, prior treatments, or other health requirements.
What is being measured
The main outcomes include treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. These are ways to track unwanted health problems after the study treatment starts.
The study also measures changes in safety laboratory parameters, vital signs, echocardiogram results, and 12-lead ECG results. These tests help researchers see whether the treatment affects the blood, the heart, or other body systems.
Because the trial is in an early phase, these safety measures are central to understanding whether the treatment can be studied further.
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. 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.
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.
Trial status and size
The trial status is Authorised. The planned enrollment is 21 participants.
With a small enrollment and a Phase 1 design, this study is focused on early research questions rather than proving long-term benefit.