Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Lutetium (177Lu) Zadavotide Guraxetan for Patients with Recurrent Grade 3 and Grade 4 Glioma

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer known as recurrent grade 3 and grade 4 glioma. The treatment being tested is called 177Lu PSMA I&T solution for injection, which is a special kind of medicine that is injected into the bloodstream. This medicine contains a radioactive substance called lutetium (177Lu) zadavotide guraxetan, which is designed to target and treat cancer cells.

The purpose of the study is to evaluate how safe and tolerable this treatment is for patients, as well as how effective it is in treating the cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor patients over a period of time to see how they respond to the treatment and to check for any side effects. The study will also look at how the treatment affects the cancer's progression and the overall survival of the patients.

Throughout the study, various assessments will be conducted, including imaging tests like MRI to evaluate the tumor's response to the treatment. The study will also assess the impact of the treatment on patients' quality of life and their ability to perform daily activities. The goal is to gather comprehensive information about the treatment's benefits and any potential risks, helping to determine its suitability for treating this type of brain cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the clinical trial, the first step involves confirming eligibility. This includes having a previous diagnosis of grade 3 or grade 4 glioma, being at least 18 years old, and having a life expectancy of more than 12 weeks.

    A negative pregnancy test is required for women of childbearing potential, and written informed consent must be provided.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status. This includes a radiological examination using MRI to confirm tumor relapse or progression.

    The Karnofsky performance status, which measures the ability to perform daily activities, must be at least 70%.

  3. Step 3

    Treatment cycle

    The treatment involves receiving the medication 177Lu PSMA I&T solution for injection through an intravenous infusion. This is administered in cycles lasting 6 to 8 weeks.

    During each cycle, no other tumor-directed treatments should be received.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess safety and tolerability. This includes tracking any adverse events and changes in health status.

    Efficacy is evaluated by measuring progression-free survival over 6 months and overall survival over 1 year.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are performed to evaluate the radiation dose to the tumor and critical organs. This involves calculating absorbed doses to various organs.

    Additional evaluations include tumor response using MRI, neurologic exams, and assessments of quality of life and performance status.

Who can join the trial?

11 criteria

  • Must have a previous diagnosis of a **WHO grade 3 or grade 4 glioma**. This means a specific type of brain tumor that has been confirmed by a doctor.
  • Women who can have children must use effective birth control. This includes women who have started having periods and have not yet gone through menopause, unless they have had surgery to permanently prevent pregnancy (such as removal of the uterus or ovaries).
  • Must agree not to receive any other treatment aimed at the tumor during each treatment cycle, which lasts 6-8 weeks.
  • Must have a tumor that has been confirmed to have returned or grown, at least 12 weeks after finishing radiation therapy, or if there is a suspicion of recurrence that makes participation in the study appropriate.
  • Must be **18 years old or older**.
  • Must provide written consent to participate in the study.
  • Women must have a negative pregnancy test within 14 days before joining the study.
  • Must have a **life expectancy of more than 12 weeks**.
  • Must have a **Karnofsky performance status of 70% or higher**, meaning they must be able to take care of themselves after receiving treatment.
  • Must show high tumor uptake on a specific diagnostic imaging test using **68Ga-PSMA**.
  • The tumor must not be suitable for further radiation therapy or surgery, and the treating doctor must believe there are no better treatment options available.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have not recovered from side effects of previous treatments.
  • Patients with a history of certain heart conditions.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

177Lu-PSMA is a type of targeted therapy used in this clinical trial. It is designed to treat patients with recurrent or progressed grade 3 and grade 4 glioma, which are types of brain tumors. This therapy works by attaching a radioactive substance, Lutetium-177, to a molecule that specifically targets cancer cells. The radioactive part helps to destroy the cancer cells while minimizing damage to the surrounding healthy tissue. The trial aims to assess how safe and tolerable this treatment is for patients, as well as how effective it is in reducing the size or growth of the tumors.

What is already known about the treatment

177Lu-PSMA – This medication is administered through a method called theranostics, which combines therapy and diagnostics, and is used for treating recurrent grade 3 and grade 4 glioma, a type of brain tumor. Currently, 177Lu-PSMA is being studied in clinical trials to assess its safety, tolerability, and effectiveness in treating these aggressive brain tumors. The main therapeutic indication for 177Lu-PSMA is its potential to target and treat cancer cells in gliomas. At the molecular level, it works by binding to a protein called PSMA, which is found on the surface of certain cancer cells, allowing the radioactive component to deliver targeted radiation to the tumor. This medication falls under the pharmacological classification of radiopharmaceuticals, which are drugs that contain radioactive substances used to diagnose or treat diseases.

Investigated diseases

Recurrent Grade 3 and Grade 4 Glioma – Glioma is a type of tumor that occurs in the brain and spinal cord, originating from glial cells. Grade 3 gliomas, also known as anaplastic gliomas, are malignant and grow more aggressively than lower-grade tumors. Grade 4 gliomas, commonly referred to as glioblastomas, are the most aggressive form, characterized by rapid growth and a tendency to infiltrate surrounding brain tissue. These tumors can cause a variety of neurological symptoms depending on their location, such as headaches, seizures, and cognitive or motor impairments. Recurrent gliomas are those that have returned after initial treatment, often exhibiting more aggressive behavior. The progression of these tumors involves increased growth and potential spread within the central nervous system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518495-31-00Protocol codeGlioma TheranosticsEstimated enrolment10 patientsSponsorNorwegian University Of Science And Technolology

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).