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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07100730 | Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma | PHASE3 | RECRUITING | 50 | — | — | Nov 2, 2025 | Nov 1, 2027 | Apr 16, 2026 | 4 | Australia, Austria +1 |
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.
Part 1 of the study is being done to identify the best dose to use for Part 2 of the study
| Arm | Type | Description |
|---|---|---|
| TLX101-Tx + Standard of Care | EXPERIMENTAL | TLX101-Tx + Lomustine |
| TLX101-Tx Only | EXPERIMENTAL | TLX101-Tx Therapy only |
| Name | Type | Description |
|---|---|---|
| TLX-101-Tx + Lomustine | COMBINATION_PRODUCT | Combination therapy with TLX-101-Tx + Lomustine |
| TLX101-Tx | RADIATION | TLX101-Tx |
Inclusion Criteria: 1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification. 2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal s...