drugset / Trial / NCT06159621

CD40 Agonist and PD-1 Inhibitor in HNSCC

NCT06159621

Phase 1 Active not recruiting 27 enrolled University of Pennsylvania
RandomizedParallel-groupOpen-labelTreatment

Summary

Prospective, open-label, phase 1 study of CD40 agonist (LVGN7409) and PD-1 inhibition (LVGN3616 or nivolumab) in patients with resectable Human Papillomavirus (HPV)-negative mucosal head/neck squamous cell carcinoma (HNSCC). This protocol proposes to study the safety and immunological effects of LVGN7409, a CD40 agonistic antibody, when administered in combination with PD-1 inhibition prior to surgical resection.

Timeline

Start
2024-07-02
Primary completion
2028-03-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator LVGN7409 Monoclonal antibody 1 mg/kg
Comparator PRADUSINSTOBART Monoclonal antibody 300 mg