Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05450744 | 131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2) | PHASE1 | RECRUITING | 12 | — | — | Apr 1, 2023 | Jun 1, 2026 | Jan 21, 2026 | 6 | Australia, Austria +1 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 131I-TLX101 + standard of care | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 131I-IPA | DRUG | 131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously |
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 gli...