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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted. 2. Are Male or Female, and aged 18-65 years of age inclusive, at the time of signing the informed consent. 3. Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded. 4. Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM. 5. Have a Karnofsky Performance Status ≥70. 6. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen. 7. 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. 8. 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). 9. 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. 10. Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child. 11. Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.

Exclusion Criteria:

1. Are unable to provide signed informed consent. 2. Have had prior treatment for glioma, excluding surgery. 3. Are unable to undergo contrast-enhanced MRI. 4. Intend to be treated with tumor-treating fields prior to progression. 5. 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. 6. Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies. 7. Have haemostaseologic conditions, precluding catheterisation or invasive procedures. 8. Have phenylketonuria. 9. Have a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders. 10. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour. 11. Pregnant, breastfeeding or planning to get pregnant during the duration of the study. 12. 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. 13. 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. 14. Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years. 15. Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment. 16. Have serious, non-healing wound, ulcer, or bone fracture. 17. Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication. 18. Have received any other IMP within 90 days prior to the planned administration of study drug. 19. Have uncontrolled Hashimoto's or Grave's disease. 20. Have on-going and unresolved Grade ≥ 1 AEs following surgical resection

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Telix International Pty Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Australia, Austria, Netherlands, New Zealand

The disease, disorder, syndrome, illness, or injury that is being studied.

Neoplastic Disease, Glioblastoma, Glioblastoma Multiforme
Arms & Interventions


Experimental: 131I-TLX101 + standard of care


Drug: - 131I-IPA

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gold Coast University Hospital, Gold Coast, Queensland, Australia


Not yet recruiting


Gold Coast University Hospital

Gold Coast, Queensland,

Royal Adelaide Hospital, Adelaide, South Australia, Australia




Royal Adelaide Hospital

Adelaide, South Australia,

Site Contact

Principal Investigator, MD


(08) 7074 0000

Melbourne, Victoria, Australia




Olivia Newton John Cancer Research Institute/Austin Health

Melbourne, Victoria,

Site Contact

Principal Investigator, MD


(03) 9496 5726

Linz, Austria


Not yet recruiting


Institut für Nuklearmedizin und Endokrinologie

Linz, ,

UNMC Utrecht, Amsterdam, Netherlands


Not yet recruiting


UNMC Utrecht

Amsterdam, ,

Mercy Hospital, Auckland, New Zealand


Not yet recruiting


Mercy Hospital

Auckland, ,

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