31I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2) (IPAX-2)

• Drug: 131I-IPA

Inclusion Criteria:

1. Understand and voluntarily sign the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 resectionsurgical removal of tissue or part/all of an organ. Tumours primarily localisedaffecting only one area of body in the infratentorial compartment will be excluded.
4. Have had prior surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence for glioblastoma, but no systemic therapy or radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells 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 Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening:7.1 Bone marrowsoft, spongy tissue found in bones that makes blood cells: 7.1.1 Leukocytes ≥3,000/mL 7.1.2 Absolute neutrophil count ≥1500/mL 7.1.3 Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding ≥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 tissuea group of cells that work together to perform a function block (frozen or paraffin-embedded) available from a previous biopsyremoval of a section of tissue to analyse for cancer cells or surgery (tumoura tissue mass that forms from groups of unhealthy cells 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.