In short
Clinical trials are studying LUTETIUM LU-177 in different cancers, including HER2-positive metastatic breast cancer and gastrointestinal neuroendocrine tumors. These studies look at safety, tolerability, biodistribution, and whether treatment can slow disease progression in specific patient groups.
Key points
- Clinical trials of LUTETIUM LU-177 are studying different cancers, mainly HER2-positive metastatic breast cancer and gastrointestinal neuroendocrine tumors. One study is a first-in-human Phase 1 trial focused on safety, tolerability, and biodistribution. Another is a Phase 3 trial looking at disease progression with scan-based measures such as CT or MRI and RECIST 1.1. The trials include patients with specific confirmed cancer types, including advanced or unresectable disease. Both studies are listed as Authorised. Together, they show that LUTETIUM LU-177 is being tested in both early and later-stage cancer research.
Trial overview
These clinical trials are studying LUTETIUM LU-177 in cancer care, with one study in breast cancer and one in neuroendocrine tumors. The trials are interventional studies, which means researchers are giving a treatment and then measuring the results.
Both studies are listed as Authorised, meaning they have been approved to proceed. The trial data show two different phases: an early Phase 1 study and a later Phase 3 study.
HER2-positive metastatic breast cancer study
The first trial is a first-in-human Phase 1 study in subjects with HER2-positive metastatic breast cancer. “First-in-human” means this is the first time the study treatment is being tested in people in this trial program.
This study is open-label, which means both the researchers and participants know what treatment is being given. It is also a two-stage, randomized trial, so participants are assigned by chance to study groups and the trial is done in two parts.
The brief summary says the study is evaluating the safety and tolerability of a single intravenous infusion of [177Lu]Lu-ABY-271. The intervention listed includes LUTETIUM LU-177 and ABY-271 given by intravenous infusion.
Neuroendocrine tumor study
The second trial is a Phase 3 study in patients with diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumor of the gastrointestinal tract. This means the tumor must be proven by tissue testing and must be either widespread or not removable by surgery.
The study title describes tandem therapy LutaPol/ltraPol, and the brief summary says the treatment uses isotope mixtures of 177Lu-DOTATATE and 90Y-DOTATATE based on personalized dosimetry. Personalized dosimetry means planning treatment based on how much radiation is expected to reach the tumor and the body.
The intervention is listed as DuoNEN solution for injection. The study aims to develop an algorithm for treating GEPNET patients using these isotope mixtures.
Endpoints and what the trials measure
In the Phase 1 breast cancer trial, the main outcomes are treatment-emergent adverse events, serious adverse events, and dose limiting toxicities. These are ways to track whether unwanted medical problems happen after treatment starts, and whether side effects are severe enough to limit dosing.
That trial also measures changes in safety laboratory parameters, vital signs, echocardiogram (ECHO), and 12-lead ECG. These tests help researchers watch the blood tests, heart function, and heart rhythm during the study.
In the Phase 3 neuroendocrine tumor trial, the primary outcome is disease progression assessed by CT or MRI according to RECIST 1.1. Disease progression means the cancer gets worse, and RECIST 1.1 is a standard scan-based method for measuring tumor change.
The scan checks are planned after 3, 6, 12, 24, 36, 49, and 60 months after completion of therapy. This long follow-up helps researchers see how the disease changes over time.
Who can participate
Eligibility is different in each study and is based on the cancer type. The breast cancer trial includes subjects with HER2-positive metastatic breast cancer.
The neuroendocrine tumor trial includes patients with diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumors of the gastrointestinal tract. This is a narrower group because the study is focused on a specific tumor type and stage.
Trial phases and status
The breast cancer study is a Phase 1 trial with 21 planned participants. Phase 1 studies usually aim to learn about safety and tolerability first.
The neuroendocrine tumor study is a Phase 3 trial with 92 planned participants. Phase 3 studies usually involve more people and focus more on whether the treatment helps control the disease.
Both trials are marked as Authorised in the source data. This shows that the studies have moved into approved clinical research activity.