drugset
drugset / Trial / NCT04651634

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

NCT04651634 ↗

Phase 2 Active not recruiting 60 enrolled MitoImmune Therapeutics
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).

Timeline

Start
2021-06-21
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject MIT-001 Unknown 20 mg Intravenous
Subject MIT-001 Unknown 40 mg Intravenous
Subject MIT-001 Unknown 60 mg Intravenous

Indications

chemotherapy-induced oral mucositis head and neck squamous cell carcinoma