Approval Probability
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Adjusted LOA
ML Risk
TLX101 · 1 trial · 6 indications
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...
TLX101 is being developed for the treatment of recurrent glioblastoma, an aggressive form of brain cancer. It is under investigation in a Phase 3 clinical trial in adults with this condition. The trial evaluates TLX101-Tx plus standard of care compared with standard of care alone.
TLX101 targets PSMA, or prostate-specific membrane antigen. It is a small molecule designed to interact with this molecular target as part of its therapeutic approach in oncology. The targeting of PSMA is the basis for its investigation in neoplastic disease, including glioblastoma.
TLX101 is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. The company is responsible for the clinical development of this small molecule oncology asset.
TLX101 is in Phase 3 clinical development. The ongoing trial is a Phase 3 study, and the drug is investigational and has not been approved by the FDA. It is being evaluated in patients with recurrent glioblastoma.
TLX101 is being studied in the Phase 3 trial NCT07100730, titled Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma. The trial is currently recruiting and plans to enroll 50 participants across Australia, Austria, Belgium, and the Netherlands.