drugset / Trial / NCT05734560

D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

NCT05734560 ↗

Phase 1/2 Recruiting 50 enrolled Darell Bigner Rockefeller University · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

Timeline

Start
2023-09-06
Primary completion
2026-10-31
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 2141-V11 Monoclonal antibody 2 mg Other
Subject 2141-V11 Monoclonal antibody 3 mg Other
Subject D2C7-IT Protein / enzyme biologic 166075 ng Other

Indications