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Neoplastic DiseasePhase 1IPAX-2NCT05450744

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)

A Phase 1 study testing 131I-IPA in people with Neoplastic Disease and Glioblastoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 5 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
131I-IPA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesin 3 countries
Study dates
1 Apr 2023to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted.
  • Are Male or Female, and aged 18 years or older, at the time of signing the informed consent.
  • Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded.
  • Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.
  • Have a Karnofsky Performance Status ≥70.
  • Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen.
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  • Have adequate organ function at Screening:
  • 7.1 Bone marrow: 7.1.1 Leukocytes ≥3,000/mL 7.1.2 Absolute neutrophil count ≥1500/mL 7.1.3 Platelets ≥100,000/mL 7.1.4 Haemoglobin ≥9g/dL 7.2 Liver function: 7.2.1 Total bilirubin ≤1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3×ULN is permitted 7.2.2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN 7.3 Renal function: 7.3.1 Serum/plasma creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min
  • Have at least 6 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived).
  • Have the capacity to understand the study and be able and willing to comply with all protocol requirements, including compliance with the radiation protection guidelines (including hospital admissions and isolation) that are applied by the treating institution to protect their contacts and the public.
  • Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child.
  • Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.

Who cannot join

  • Are unable to provide signed informed consent
  • Have had prior treatment for glioma, excluding surgery.
  • Are unable to undergo contrast-enhanced MRI.
  • Intend to be treated with tumor-treating fields prior to progression.
  • Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g., tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy.
  • Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
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  • Have haemostaseologic conditions, precluding catheterisation or invasive procedures.
  • Have had phenylketonuria diagnosis previously
  • Have any medical condition that in the opinion of the Investigator may interfere with the participant's ability to adhere to the study or may impose a risk to the participant's health.
  • Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour.
  • Pregnant, breastfeeding or planning to get pregnant during the duration of the study.
  • Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.
  • Have presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or unable to comply with study requirements. HIV-positive participants may be included in the study if they are on a stable dose of anti-retroviral therapy.
  • Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.
  • Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
  • Have serious, non-healing wound, ulcer, or bone fracture.
  • Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
  • Have received any other IMP within 90 days prior to the planned administration of study drug.
  • Have uncontrolled Hashimoto's or Grave's disease
  • Have on-going and unresolved Grade ≥ 1 AEs following surgical resection

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Gold Coast University Hospital

    Gold Coast, Queensland, 4215

  • Olivia Newton John Cancer Research Institute/Austin Health

    Melbourne, Victoria

Other trials in Australia

Austria1 site

  • Institut für Nuklearmedizin und Endokrinologie

    Linz

Other trials in Austria

Netherlands1 site

  • UNMC Utrecht

    Utrecht, 3051

Other trials in Netherlands

About this study

Official title: A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.

Being tested
131I-IPA
Keywords
Glioblastoma
Medical subject headings
Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 131I-IPADrug

    Also called 18F-FET

    131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously

Study groups in NCT05450744
Study groupRoleWhat they receive
131I-TLX101 + standard of careExperimentalNot described
Receives: Drug: 131I-IPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate and the grade (severity) of DLTs

    Incidence rate and the grade (severity) of DLTs based on the occurrence of Adverse Events (AEs) reported according to the NCI CTCAE v6.0. DLTs include any grade ≥ 3 events considered possibly related to the study drug, but excludes cerebral oedema, and haematological toxicity.

    Measured: 8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.

  2. Safety, tolerability and RP2D

    Assessing TEAEs type according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0.

    Measured: From screening until end of study, assessed over 62 weeks. TEAEs - units are frequency (percentage) and severity. Laboratory - safety laboratory including liver functions test, report mean and out of range.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start1 Apr 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 ascending dose
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450744
Sponsor's protocol ID
131I-TLX-101-002 (IPAX-2)
Acronym
IPAX-2
Status last verified
Aug 2026
First submitted
22 Apr 2022
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 131I-IPA in people with Neoplastic Disease and Glioblastoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate and the grade (severity) of DLTs (time frame: 8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05450744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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