drugset / Trial / NCT05084430
Study of Pembrolizumab and M032 (NSC 733972)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |