Study of Mitazalimab Injection Treatment for Patients with High-Risk Oral Potentially Malignant Disorders

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What is this study about?

This study focuses on Oral Potentially Malignant Disorders (OPMD), which are conditions in the mouth that have a risk of becoming cancerous. These conditions include different types of abnormal patches in the mouth such as leucoplakia, erythroplakia, and erythro-leukoplakia. The study will test a new treatment called mitazalimab, which is given as an injection directly into the affected areas of the mouth. This medication works by stimulating the body’s immune system to fight against these potentially dangerous mouth conditions.

The main purpose of this study is to determine how effective a short course of mitazalimab treatment is for people with high-risk mouth disorders. During the study, participants will receive the medication through solution for infusion directly into the affected areas of their mouth. The total treatment period will last up to 8 weeks, with specific doses calculated based on body weight.

The study will monitor changes in the mouth conditions over time, particularly focusing on improvements after 6 months of treatment. Participants will need to provide mouth tissue samples and saliva samples throughout the study period. The overall monitoring of participants will continue for several years to track long-term outcomes and any changes in the mouth conditions.

1 Initial evaluation and diagnosis

Your diagnosis must confirm presence of high risk oral potentially malignant disorder (OPMD), which includes conditions like leucoplakia, erhytroplakia, or erhytro-leukoplakia

The affected area must be at least 2 cm in size

A tissue sample (biopsy) will be taken from your oral cavity for examination

You will need to provide saliva samples for study purposes

2 Treatment administration

You will receive mitazalimab through injection directly into the affected area (intralesional immunotherapy)

The medication will be given as a solution for injection

This will be a short course of treatment

3 6-month evaluation

Your response to treatment will be evaluated after 6 months

This includes examining changes in your condition and tissue samples

You will complete quality of life questionnaires

Additional tissue samples and tests will be conducted to monitor your condition

4 Follow-up period

You will be monitored for up to 3 years

Quality of life assessments will continue every three months for 18 months

Regular examinations will check for any changes in your condition

Additional tissue samples may be taken if needed

5 Final evaluation

The study will assess the long-term effectiveness of the treatment

Final evaluations will include tissue examination and quality of life assessment

The total study duration may extend until January 2030

Who Can Join the Study?

Must sign a written consent form to participate in the study
Must be at least 18 years old (male or female)
Must have an ECOG Performance Status between 0-2 (a measure of a person’s ability to perform daily activities and self-care)
Must have a diagnosis of high-risk OPMD (Oral Potentially Malignant Disorder) meeting at least one of these conditions:
- Multiple lesions (2 or more) or connected lesions of 3 cm or larger, or a single lesion 4 cm or larger with tissue changes (dysplasia)
- Lesions present in all four areas of the oral cavity
- At least one lesion with moderate tissue changes
- Lesions with severe tissue changes
Must have oral lesions that are at least 2 centimeters in size
Must be willing to undergo oral tissue biopsies for the study
Must be willing to provide saliva samples
If previously diagnosed with oral cavity cancer, at least 2 years must have passed since completing treatment

Who Cannot Join the Study?

History of autoimmune diseases (conditions where the body’s immune system attacks its own tissues)
Active or chronic viral infections including hepatitis B, hepatitis C, or HIV
Current or recent treatment with immunosuppressive medications (drugs that reduce immune system activity)
Previous treatment with cancer immunotherapy within the last 6 months
Presence of active oral infections or severe gum disease
History of allergic reactions to similar medications
Pregnant or breastfeeding women
Uncontrolled medical conditions such as diabetes, heart disease, or high blood pressure
Current participation in other clinical trials
Unable to provide informed consent
History of malignant tumors (cancer) in the past 5 years
Significant laboratory test abnormalities
Current systemic corticosteroid treatment (medications like prednisone that affect the whole body)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	28.07.2025

Trial locations

Investigated drugs:

Mitazalimab

Mitazalimab is an immunotherapy medication that works by stimulating the body’s immune system. It is injected directly into the affected areas of the mouth (intralesional injection) to treat potentially pre-cancerous conditions of the oral cavity. This medication aims to help prevent the transformation of high-risk oral lesions into cancerous growths by enhancing the body’s natural defense mechanisms.

Investigated diseases:

Head and neck cancer

Oral Potentially Malignant Disorder (OPMD) – A group of conditions affecting the mouth’s soft tissues that show abnormal changes which may develop into oral cancer. These disorders typically appear as white or red patches in the mouth, particularly on the tongue, inside of cheeks, or lips. The condition can progress gradually, with tissue changes becoming more pronounced over time. Some cases may show varying degrees of cell changes (dysplasia) when examined under a microscope. OPMD can affect multiple areas of the mouth simultaneously and may persist or evolve over months or years.

Trial ID:

2025-521490-13-00

Protocol code:

APHRODITE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Mitazalimab Injection Treatment for Patients with High-Risk Oral Potentially Malignant Disorders

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?