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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma; Glioblastoma Multiforme; Neoplastic Disease
• Intervention / Treatment: Drug: 131I-IPA

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
      • Contact: Adrain Lee, MD; Phone Number: +61 2 9463 1171; Email: adrian.lee@health.nsw.gov.au
      • Principal Investigator: Adrian Lee, MD
  • Queensland
    • Gold Coast, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast University Hospital
      • Contact: Wade Pullin, Dr; Phone Number: +61756190600; Email: wade.pullin@health.qld.gov.au
      • Principal Investigator: Wade Pullin, Dr
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Principal Investigator, MD; Phone Number: (08) 7074 0000; Email: Health.CALHNResearchEthics@sa.gov.au
  • Victoria
    • Melbourne, Victoria, Australia
      • Recruiting
      • Olivia Newton John Cancer Research Institute/Austin Health
      • Contact: Principal Investigator, MD; Phone Number: (03) 9496 5726; Email: enquiries@onjcri.org.au
• Austria
  • Linz, Austria
    • Recruiting
    • Institut für Nuklearmedizin und Endokrinologie
    • Contact: Principal Investigator; Phone Number: +61383180090; Email: info@telixpharma.com
• Netherlands
  • Utrecht, Netherlands, 3051
    • Recruiting
    • UNMC Utrecht
    • Contact: Principal Investigator; Phone Number: 383180090; Email: info@telixpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 years or older, 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 had phenylketonuria diagnosis previously
9. 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.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: 18F-FET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.
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.	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.

Collaborators and Investigators

• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Glioblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Glioblastoma; (18F)fluoroethyltyrosine
• Other Study ID Numbers: 131I-TLX-101-002 (IPAX-2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No