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LUTETIUM LU-177

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.

Table of contents

Trial overview

These clinical trials are studying LUTETIUM LU-177 in cancer care, with one study in breast cancer and one in neuroendocrine tumors.[1][2] The trials are interventional studies, which means researchers are giving a treatment and then measuring the results.[1][2]

Both studies are listed as Authorised, meaning they have been approved to proceed.[1][2] The trial data show two different phases: an early Phase 1 study and a later Phase 3 study.[1][2]

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.[1] “First-in-human” means this is the first time the study treatment is being tested in people in this trial program.[1]

This study is open-label, which means both the researchers and participants know what treatment is being given.[1] 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.[1]

The brief summary says the study is evaluating the safety and tolerability of a single intravenous infusion of [177Lu]Lu-ABY-271.[1] The intervention listed includes LUTETIUM LU-177 and ABY-271 given by intravenous infusion.[1]

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.[2] This means the tumor must be proven by tissue testing and must be either widespread or not removable by surgery.[2]

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.[2] Personalized dosimetry means planning treatment based on how much radiation is expected to reach the tumor and the body.[2]

The intervention is listed as DuoNEN solution for injection.[2] The study aims to develop an algorithm for treating GEPNET patients using these isotope mixtures.[2]

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.[1] These are ways to track whether unwanted medical problems happen after treatment starts, and whether side effects are severe enough to limit dosing.[1]

That trial also measures changes in safety laboratory parameters, vital signs, echocardiogram (ECHO), and 12-lead ECG.[1] These tests help researchers watch the blood tests, heart function, and heart rhythm during the study.[1]

In the Phase 3 neuroendocrine tumor trial, the primary outcome is disease progression assessed by CT or MRI according to RECIST 1.1.[2] Disease progression means the cancer gets worse, and RECIST 1.1 is a standard scan-based method for measuring tumor change.[2]

The scan checks are planned after 3, 6, 12, 24, 36, 49, and 60 months after completion of therapy.[2] This long follow-up helps researchers see how the disease changes over time.[2]

Who can participate

Eligibility is different in each study and is based on the cancer type.[1][2] The breast cancer trial includes subjects with HER2-positive metastatic breast cancer.[1]

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.[2] This is a narrower group because the study is focused on a specific tumor type and stage.[2]

Trial phases and status

The breast cancer study is a Phase 1 trial with 21 planned participants.[1] Phase 1 studies usually aim to learn about safety and tolerability first.[1]

The neuroendocrine tumor study is a Phase 3 trial with 92 planned participants.[2] Phase 3 studies usually involve more people and focus more on whether the treatment helps control the disease.[2]

Both trials are marked as Authorised in the source data.[1][2] This shows that the studies have moved into approved clinical research activity.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-518360-13-00 Phase 1 HER2-positive metastatic breast cancer Authorised 21
2024-516503-17-01 Phase 3 Diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumor of the gastrointestinal tract Authorised 92

FAQ

  • What is being studied in clinical trials of LUTETIUM LU-177? The trials are testing LUTETIUM LU-177 in cancer patients to see how safe it is and whether it may help control disease. The main studies here involve HER2-positive metastatic breast cancer and gastrointestinal neuroendocrine tumors.
  • Who may take part in these trials? One trial includes subjects with HER2-positive metastatic breast cancer. Another includes patients with diagnosed and histopathologically confirmed diffuse or locally unresectable, well or intermediate differentiated neuroendocrine tumors of the gastrointestinal tract.
  • What trial phases are represented? The data include a Phase 1 first-in-human study and a Phase 3 study. Phase 1 usually focuses on safety and tolerability, while Phase 3 looks more closely at whether the treatment works in a larger group.
  • What outcomes are being measured? The Phase 1 study measures treatment-emergent adverse events, serious adverse events, dose limiting toxicities, and changes in safety tests such as lab values, vital signs, echocardiogram, and ECG. The Phase 3 study measures disease progression using CT or MRI and RECIST 1.1 criteria.
  • Are these studies already open? Both trials in the data are listed as Authorised. That means they have been approved to move forward.

Ongoing Clinical Trials on LUTETIUM LU-177

  • Study on the Safety and Effects of Lutetium Lu-177 and ABY-271 in Patients with HER2-Positive Metastatic Breast Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Sweden

  • Study of Lutetium-177 and Yttrium-90 DOTATATE combination therapy for patients with inoperable gastrointestinal neuroendocrine tumors

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Phase 1: An early study stage that mainly checks safety, tolerability, and how the treatment behaves in the body.
  • Phase 3: A later study stage with more participants that looks more closely at whether the treatment helps and how well it works.
  • Safety: Whether a treatment can be given without causing unacceptable harm.
  • Tolerability: How well patients can handle a treatment and its effects.
  • Biodistribution: How a treatment spreads through the body and where it goes, such as tumors or important organs.
  • HER2-positive: A type of breast cancer that has a high amount of the HER2 protein.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Neuroendocrine tumor: A tumor that starts in hormone-making cells and nerve-like cells.
  • Histopathologically confirmed: Confirmed by looking at tissue under a microscope.
  • Unresectable: Not able to be removed by surgery.
  • RECIST 1.1: A standard way to measure whether a tumor has grown, shrunk, or stayed the same on scans.
  • CT or MRI: Imaging tests that create detailed pictures of the inside of the body.

References

  1. https://clinicaltrials.gov/study/2024-518360-13-00
  2. https://clinicaltrials.gov/study/2024-516503-17-01