drugset / Trial / NCT05084430

Study of Pembrolizumab and M032 (NSC 733972)

NCT05084430 ↗

Phase 1/2 Recruiting 28 enrolled University of Alabama at Birmingham
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).

Timeline

Start
2022-02-25
Primary completion
2027-03-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject M032 Unknown 10000 unknown Other
Subject M032 Unknown 100000 unknown Other
Subject M032 Unknown 1e+06 unknown Other
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous