drugset / Trial / NCT04782609

Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma

NCT04782609 ↗

Phase 1 Terminated 7 enrolled Samus Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Icapamespib Small molecule 20 mg Oral