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

(MIT-001 Trial)

Not currently recruiting at 25 trial locations

Overseen By Jinsang Jung

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MitoImmune Therapeutics

Must be taking: Cisplatin

Must not be taking: Cetuximab

Disqualifiers: Active mucositis, Metastatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether MIT-001, an experimental treatment, can prevent oral mucositis, a painful mouth condition, in patients with head and neck cancer undergoing chemoradiotherapy. Researchers will compare three doses of MIT-001 against a placebo to determine the most effective option. Candidates include those who have not yet started treatment for advanced head and neck cancer and plan to receive specific radiation therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you do not receive certain targeted or immune therapies during the study.

Is there any evidence suggesting that MIT-001 is likely to be safe for humans?

Research has shown that MIT-001, a drug tested to prevent painful mouth sores in cancer patients, is generally safe. In studies involving patients with conditions like lymphoma or multiple myeloma, MIT-001 was well-tolerated. These studies reported only mild side effects, and most patients managed the treatment well.

MIT-001 blocks harmful molecules that cause inflammation, potentially reducing the painful sores some cancer treatments can cause. Overall, the available evidence suggests that MIT-001 is safe for patients, and further research will help confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for oral mucositis in head and neck cancer patients, like mouth rinses and pain relievers, focus on managing symptoms rather than preventing them. MIT-001 is unique because it aims to prevent oral mucositis from occurring in the first place. Researchers are excited about MIT-001 because it is being tested in different doses (20 mg, 40 mg, and 60 mg), which could potentially offer more tailored and effective prevention options. Unlike the standard approaches, MIT-001 might provide a proactive solution, reducing the discomfort and complications associated with this condition.

What evidence suggests that MIT-001 could be effective for preventing oral mucositis in head and neck cancer patients?

Research has shown that MIT-001 might help prevent painful mouth sores in patients receiving treatment for head and neck cancer. In studies with cancer patients, MIT-001 reduced inflammation by neutralizing harmful molecules. This decrease in inflammation can help stop mouth sores from developing. This trial tests MIT-001 at different doses (20 mg, 40 mg, and 60 mg) to find the most effective one. Early results suggest that MIT-001 could be a promising option for patients seeking to lessen the side effects of cancer therapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Jinsang Jung, M.Pharm

Principal Investigator

MitoImmune Therapeutics

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIT-001 or placebo during concurrent chemoradiotherapy (CCRT) for HNSCC

6-8 weeks

Weekly visits (in-person) during CCRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MIT-001

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123088298

Evaluation of the Safety and Efficacy for Oral Mucositis ... The current clinical study was designed to evaluate the safety, efficacy by prevention of OM and pharmacokinetics of MIT-001 in patients with lymphoma or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05493800

NCT05493800 | Evaluate the Safety and Efficacy for Oral ... Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning ...

3. withpower.com withpower.com/trial/mit-001-for-oral-mucositis-prevention-in-head-and-neck-cancer-patients-35b96

MIT-001 for Oral Mucositis Prevention in Head and Neck ... This trial tests MIT-001, a drug that reduces harmful molecules to prevent inflammation, in patients with advanced head and neck cancer undergoing ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-12592

MIT-001 for Prevention of CCRT-Induced OM in HNSCC ... The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy ...

5. redjournal.org redjournal.org/article/S0360-3016(22)03683-5/pdf

Phase 2a Randomized Trial to Assess the Safety and ... This phase 2a, multi-institutional trial was designed to assess the safety and feasibility of 3 schedules of a fixed concentration of RRx-001; a standard-of- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12433216/

Pharmacokinetic and Safety Profiles of MIT-001, a Novel ... MIT-001 is a novel ferroptosis inhibitor with therapeutic potential for oxidative stress-related diseases. This study aimed to evaluate the ...