drugset / Trial / NCT05304663
Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Open label phase I study in subjects with glioblastoma at first progression to explore two different administration schedules of lomustine for the combination with L19TNF (ARM 1 and ARM 2). Patients will be assigned in an alternating fashion to ARM 1 "Fractionating lomustine" or ARM 2 "Priming with L19TNF" as long as both treatment arms are open. Should one treatment arm be stopped as more or equal to two dose limiting toxicities occur in this treatment arm, then all remaining patients will be assigned to the treatment arm that is still open until also this treatment arm will be stopped.
Timeline
- Start
- 2022-06-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lomustine | Small molecule | 60 mg/m2 | — |
| Subject | Lomustine | Small molecule | 75 mg/m2 | — |
| Subject | Lomustine | Small molecule | 90 mg/m2 | — |
| Subject | Lomustine | Small molecule | 110 mg/m2 | — |
| Subject | Onfekafusp alfa | Protein / enzyme biologic | 10 ug/kg | — |