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

ConditionsNeoplastic Disease Glioblastoma Glioblastoma Multiforme

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: 131I-TLX101 + standard of careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.