In short
GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 is an investigational radioligand therapy being studied in a Phase 1 clinical trial for metastatic clear cell renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The trial is authorised in the European Union and plans to enrol 35 adult patients. The study is designed to find the maximum tolerated dose and to assess dose-limiting toxicities during the first six weeks of treatment.
Key points
- Investigational substance studied as a radioligand therapy labelled with terbium-161 (161Tb).
- Condition studied: metastatic clear cell renal cell carcinoma, a form of kidney cancer that has spread.
- Phase 1 trial with an authorised status in the EU Clinical Trials Information System.
- 35 participants are planned to be enrolled in this single-centre study.
- Main goal: to determine the maximum tolerated dose and the recommended dose for further study.
- Primary endpoint: dose-limiting toxicities occurring during the first treatment cycle of six weeks.
What is GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2?
GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 is the full chemical name of an investigational substance that is being studied as a radioligand therapy. In the clinical trial record, this substance is referred to as 161Tb-PSMA-1, which indicates that the molecule is labelled with the radioactive isotope terbium-161 and is designed to target the prostate-specific membrane antigen (PSMA). The substance is not an authorised medicine; it is still in the early stages of clinical research. The trial record lists it under the EU Clinical Trials Information System with the identifier 2026-525526-38-00.
How does GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 work?
The full name GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 describes a peptide-based molecule. In the trial, it is used in the form 161Tb-PSMA-1, which combines a PSMA-targeting peptide with the radioactive isotope terbium-161. PSMA is a protein found on the surface of certain cancer cells, including some kidney cancer cells. By attaching to PSMA, the radioligand is designed to deliver radiation directly to cancer cells while limiting exposure to healthy tissue. Terbium-161 emits both beta particles and Auger electrons, which can damage cancer cell DNA. The trial record describes the study as evaluating 161Tb-PSMA therapy in patients with metastatic clear cell renal cell carcinoma.
Which conditions is GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 studied for?
- Metastatic clear cell renal cell carcinoma — a type of kidney cancer that has spread beyond the kidney to other parts of the body. This is the only condition listed in the current trial record.
How is GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 given?
According to the trial record, 161Tb-PSMA-1 is given as an intravenous injection at a dose of 11.5 gigabecquerel (GBq). A gigabecquerel is a unit used to measure radioactivity. The trial also uses a second substance, gallium-68 gozetotide, given intravenously at a dose of 2.2 megabecquerel per kilogram of body weight. Gallium-68 gozetotide is a diagnostic imaging agent used to visualise PSMA-positive tumours before treatment.
What do the clinical trials show?
The clinical research on GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2 consists of one authorised Phase 1 trial. Phase 1 trials are the earliest stage of testing in humans and focus on safety, dosing and tolerability rather than effectiveness. The trial is a single-centre, open-label study, which means both the researchers and the participants know which treatment is being given. It plans to enrol 35 adult patients with metastatic clear cell renal cell carcinoma.
The primary outcome of the trial is the occurrence of dose-limiting toxicities. These are side effects severe enough to prevent increasing the dose further, and they are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0. The toxicities are assessed during the first treatment cycle, which lasts six weeks. The study aims to determine the maximum tolerated dose and the recommended dose for extension, which is the dose that would be used in future studies.
The trial status is authorised, meaning the study has received regulatory approval and may proceed with enrolling participants. No results from this trial are available yet, as it is still in the early phase of clinical development.
What side effects are known?
The trial record does not provide a list of known side effects for GLU-CO-GLU'-AMC-AHX-GLU-GLU-GLU-LYS-NH2. Since this is a Phase 1 study, the main purpose is to identify side effects and determine which dose-limiting toxicities occur during the first six-week treatment cycle. The primary outcome measure specifically tracks adverse events assessed as related to 161Tb-PSMA-1 and graded according to standard criteria.