131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Limited
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 131I-IPA
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov