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Also known as [177Lu]Lu-NeoB
Lu-NeoB · 1 trial · 1 indication
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT observation period of \[177Lu\]Lu-NeoB. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. In Group 1 (newly diagnosed GBM), the DLT observation period is defined as a total of 8 weeks (56 days) from the first administration of \[177Lu\]Lu-NeoB, to cover the entire duration of concomitant RT and TMZ combination with the first two administrations of \[177Lu\]Lu-NeoB. In Group 2 (recurrent GBM), the DLT observation period is 6 weeks (42 days) starting from the first administration of \[177Lu\]Lu-NeoB (at Week 1 Day 1) and accounting for assessment of the safety profile during 2 full cycles of \[177Lu\]Lu-NeoB.
| Arm | Type | Description |
|---|---|---|
| [177Lu]Lu-NeoB in Combination with Radiotherapy (RT) and Temozolomide (TMZ) | EXPERIMENTAL | In newly diagnosed glioblastoma |
| [177Lu]Lu-NeoB as Single Agent | EXPERIMENTAL | In recurrent glioblastoma |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-NeoB | DRUG | Radiopharmaceutical solution for infusion |
| [68Ga]Ga-NeoB | DRUG | Either provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection |
| Temozolomide | OTHER | Capsules/ lyophilized powder in single-dose vial for reconstitution. |
Key Inclusion Criteria/Common Criteria (Group 1 - Newly diagnosed glioblastoma, Group 2 - Recurrent glioblastoma): 1. Signed informed consent must be obtained prior to participation in the study 2. Age \>= 18 years 3. Histologically confirmed glioblastoma according to WHO classification established...
Lu-NeoB is an investigational small molecule being studied for the treatment of newly diagnosed and recurrent glioblastoma. It is a radioligand therapy that delivers radiation directly to tumor cells. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Lu-NeoB is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for glioblastoma.
Lu-NeoB is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing Phase 1 trial is a dose-finding study designed to evaluate the safety, tolerability, and preliminary efficacy of the drug in patients with glioblastoma.
Lu-NeoB is being evaluated in a single active Phase 1 clinical trial with the identifier NCT05739942. This study is a dose-finding trial enrolling 42 patients with newly diagnosed and recurrent glioblastoma. The trial is active but not recruiting participants and is being conducted in the United States, France, Germany, Italy, Portugal, and Spain.
Yes, Lu-NeoB is also known as [177Lu]Lu-NeoB. The name [177Lu]Lu-NeoB refers to the radiolabeled form of the drug, where the lutetium-177 isotope is attached to the NeoB molecule. Both names refer to the same investigational therapy being developed for glioblastoma.