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

NCT04651634 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-06

No results posted yet for this study

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).

Conditions

Interventions

DRUG

MIT-001 plus CCRT

MIT-001 IV-infusion plus CCRT

Sponsors & Collaborators

  • MitoImmune Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jinsang Jung, M.Pharm · MitoImmune Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651634 on ClinicalTrials.gov