| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05739942 | Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma | PHASE1 | ACTIVE NOT_RECRUITING | 42 | — | — | May 15, 2024 | Nov 8, 2028 | May 14, 2026 | 16 | United States, France +4 |
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...