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TLX-101-Tx+ Lomustine · 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...
TLX-101-Tx plus Lomustine is an investigational combination therapy being studied for the treatment of recurrent glioblastoma, a type of brain cancer. It is currently in Phase 3 clinical development for patients with this condition. The therapy is being evaluated against standard of care alone in a controlled clinical trial.
TLX-101-Tx plus Lomustine is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting a Phase 3 clinical trial of this combination therapy for recurrent glioblastoma.
TLX-101-Tx plus Lomustine is in Phase 3 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The drug has received orphan drug designation from the FDA, which is granted to therapies intended to treat rare diseases.
TLX-101-Tx plus Lomustine is being studied in a Phase 3 clinical trial with the identifier NCT07100730. This trial is recruiting patients with recurrent glioblastoma and is being conducted in Australia, Austria, Belgium, and the Netherlands. The study has an enrollment target of 50 participants aged 18 years and older.
Yes, TLX-101-Tx plus Lomustine is the same as TLX-101-Tx + Lomustine. These are two different ways of writing the same combination therapy name. The drug is being developed by Telix Pharmaceuticals Limited for the treatment of recurrent glioblastoma.