drugset / Trial / NCT04782609
Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a 2-part multicenter Phase 1b study designed to test icapamespib in patients with recurrent brain lesions. Part 1 of the trial will be a standard 3 by 3 dose escalation design where different doses are examined. Part 2 will be a dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D). The RP2D is defined as the dose level recommended for further clinical study, or the highest dose tested.
Timeline
- Start
- 2021-12-27
- Primary completion
- 2022-11-04
- Completion
- 2022-11-04
Outcome
Outcome not reported
Stopped: “Samus Therapeutics Company Closure”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Icapamespib | Small molecule | 20 mg | Oral |