MIT-001 for Oral Mucositis Prevention in Head and Neck Cancer Patients

(MIT-001 Trial)

Recruiting at15 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MitoImmune Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests MIT-001, a drug that reduces harmful molecules to prevent inflammation, in patients with advanced head and neck cancer undergoing chemoradiotherapy. The goal is to prevent painful mouth sores by protecting cells and blocking inflammation pathways.

Research Team

Jinsang Jung, M.Pharm

Principal Investigator

MitoImmune Therapeutics

Eligibility Criteria

This trial is for adults with a specific type of throat cancer (HNSCC) that hasn't been treated yet. They should be in good physical shape, not pregnant, and planning to get standard chemo with cisplatin and targeted radiation therapy. People can't join if they've had recent surgery for HNSCC, have active mouth sores, severe allergies to platinum drugs like cisplatin, or any other serious health issues.

Inclusion Criteria

I can carry out all my usual activities without help.

My cancer is in the mouth or throat and is either at an advanced stage or HPV-positive.

I am scheduled for weekly cisplatin treatments for 5 to 7 weeks.

Exclusion Criteria

I currently have mouth sores.

I do not have any serious illnesses or infections that would stop me from joining the study.

I had surgery for head and neck cancer less than 4 weeks ago.

Treatment Details

Interventions

• MIT-001 (Other)

Trial Overview The study tests MIT-001's ability to prevent mouth sores caused by chemoradiotherapy in throat cancer patients. Participants will receive one of three different doses of MIT-001 or a placebo alongside their standard cancer treatment regimen.

Participant Groups

Group I: 60 mg Experimental Treatment 1 Intervention

MIT-001 60 mg

Group II: 40 mg Experimental Treatment 1 Intervention

MIT-001 40 mg

Group III: 20 mg Experimental Treatment 1 Intervention

MIT-001 20 mg

Group IV: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

MitoImmune Therapeutics

Lead Sponsor

Trials

3

Recruited

160+