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Study of iodofalan (131I) and lomustine combination therapy compared to lomustine alone in patients with first recurrent glioblastoma

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What is this trial about?

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

This clinical trial focuses on patients with glioblastoma, a type of brain tumor, that has returned after initial treatment. The study tests a new treatment approach combining two medications: 131I-TLX101 (given by intravenous injection) and lomustine (taken as oral capsules). The purpose is to determine if using these treatments together helps patients live longer compared to using lomustine alone.

The study has multiple parts. In the first part, researchers will determine the safest and most effective dose of the combination treatment. In the second part, some patients will receive both medications while others will receive only lomustine. The treatment involves regular doses of lomustine, while 131I-TLX101 is given through an intravenous injection. The study will track how patients respond to the treatment and monitor any side effects that may occur.

Before joining the study, patients must undergo special imaging called FET PET scan to confirm their tumor status. This scan uses a special substance that helps doctors see if the treatment might be suitable for the patient. Throughout the study, patients will have regular check-ups, including blood tests, physical examinations, and quality of life assessments to monitor their health and response to treatment.

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

    Initial treatment phase

    You will receive two types of treatment: TLX101-Tx (given through a vein) and lomustine (taken by mouth)

    Your treatment will be divided into different parts to ensure safety and find the right dose

    Your doctor will monitor how your body responds to the treatment through regular health checks

  2. Step 2

    Health monitoring

    Regular physical examinations will be performed

    Blood tests will be taken to check your blood cell counts, liver function, and kidney function

    Your heart activity will be monitored through ECG (heart rhythm test)

    You will complete quality of life questionnaires about your symptoms and how you feel

  3. Step 3

    Imaging tests

    You will have regular brain scans (MRI) to check how your tumor is responding to treatment

    Special scans called SPECT imaging will be done to measure how the treatment is distributed in your body

    Additional scans called PET will be performed to examine tumor activity

  4. Step 4

    Treatment monitoring

    Blood and urine samples will be collected to measure treatment levels in your body

    Side effects will be tracked and recorded using a standardized rating system

    Your neurological symptoms will be regularly assessed

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to have regular check-ups

    Brain scans will be performed to monitor your condition

    The study will continue until late 2027

Who can join the trial?

17 criteria

  • Age 18 years or older
  • Confirmed diagnosis of glioblastoma (a type of brain tumor) that has come back after initial treatment
  • Evidence of tumor recurrence shown on brain scans at least 3 months after completing radiation therapy
  • Must have specific tumor markers visible on special brain imaging called FET PET scan
  • Must be able to perform daily activities independently or with minimal assistance (ECOG score 0-2 or KPS score 70 or higher)
  • Must have adequate blood test results including:
    • Platelet count of at least 100,000 per microliter
    • White blood cell count of at least 1,500 per microliter
    • Hemoglobin level above 10 g/dL without recent blood transfusions
    • Must have normal or mildly abnormal liver function tests
    • Must have adequate kidney function
    • For women who can become pregnant:
      • Must have a negative pregnancy test
      • Must not be breastfeeding
      • Must use effective birth control during treatment and for 6 months after
      • For men:
        • Must use condoms during treatment and for 3 months after
        • Must not donate sperm during treatment and for 6 months after
        • Must be able to understand and follow study requirements
        • If taking steroids, the dose must be stable for at least 7 days before starting the study

Who cannot join the trial?

15 criteria

  • Prior diagnosis of any cancer other than glioblastoma within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in-situ
  • History of severe allergic reactions to medications or contrast agents
  • Pregnant or breastfeeding women
  • Active, uncontrolled infections requiring treatment
  • Significant heart problems including heart failure, unstable heart rhythm, or recent heart attack (within 6 months)
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function tests
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study
  • Participation in another clinical trial within 4 weeks before this study
  • Unable to undergo MRI (magnetic resonance imaging) scans
  • History of bleeding in the brain
  • Current use of blood thinners that cannot be safely stopped
  • Mental conditions that could interfere with following study procedures
  • Known HIV (human immunodeficiency virus) infection or active hepatitis
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Investigated drugs

  • Iodofalan (131I)

    is a radioactive medication administered through injection. It is designed to target and treat brain tumors, specifically recurrent glioblastoma. This medication works by delivering targeted radiation therapy directly to cancer cells.

  • Lomustine

    is an oral chemotherapy medication used to treat brain tumors. It belongs to a group of drugs called alkylating agents, which work by stopping or slowing the growth of cancer cells. It is commonly used in the treatment of glioblastoma and other brain cancers.

  • TLX101-Tx

    is the investigational name for the Iodofalan (131I) solution for injection. This targeted radiation therapy is being studied both alone and in combination with lomustine to determine if it can improve survival rates for patients with recurrent glioblastoma.

What is already known about the treatment

  • Iodofalan (131I)

    A radioactive therapeutic agent administered via injection, specifically designed for treating recurrent glioblastoma, a type of aggressive brain tumor. This investigational medication combines iodine-131 radioisotope with a targeting molecule that helps deliver radiation directly to tumor cells. Currently being studied in clinical trials, it works by emitting targeted radiation that damages cancer cell DNA, potentially offering a new treatment option for patients whose glioblastoma has returned after initial treatment.

  • Lomustine

    An oral chemotherapy medication from the nitrosourea family, commonly used in the treatment of brain tumors, including recurrent glioblastoma. This medication crosses the blood-brain barrier and works by interfering with cancer cell DNA, preventing tumor cells from dividing and growing. It is typically administered in cycles and has been an established treatment option for brain tumors, often used either alone or in combination with other therapies.

Investigated diseases

Glioblastoma - A type of brain cancer that forms from glial cells, which normally support and protect nerve cells in the brain. It is characterized by fast-growing tumors that develop in the brain's supportive tissue. The disease typically causes symptoms such as headaches, nausea, vomiting, and seizures as the tumor grows and creates pressure within the brain. Glioblastoma can also cause changes in mental function, mood, or personality, depending on which part of the brain is affected. The tumor can affect different parts of the brain, leading to various neurological symptoms such as weakness on one side of the body, memory problems, or speech difficulties.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521785-10-00Protocol code131I-TLX-101-003Estimated enrolment85 patientsSponsorTelix Pharmaceuticals (Innovations) Pty Limited

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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).