IPAX-2: This phase I study is seeking to evaluate the safety of increasing radioactive dose levels of 131I-TLX101 when given in addition to best standard of care treatment in people with newly diagnosed glioblastomaA Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Exclusion

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