Could a simple pastille stop mouth cancer before it starts?
NCT ID NCT05865028
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether APG-157, a plant-based pastille taken three times daily, can shrink or eliminate precancerous growths in the mouth. Researchers will enroll 32 adults with moderate to severe oral dysplasia or carcinoma in situ. The goal is to see if the treatment reduces lesion size and improves tissue health over up to three 4-week cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APG-157 (a plant-based compound taken as a pastille)
- What this could lead to
- If it works, this could point toward a non-surgical treatment for precancerous mouth lesions, potentially preventing oral cancer.
- What could go wrong
- This is a small early-phase trial with only 32 people, so results may not apply broadly. The treatment may not shrink lesions or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients age \> 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ (CIS) and a visible lesion. Sites include all oral cavity as well as oropharyngeal dysplasia that is accessible in the outpatient clinic. 2. Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam. 3. Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy 4. Willing to provide blood, oral rinse and tissue from diagnostic biopsies 5. Leukocytes \>=3,000/microliter 6. Absolute neutrophil count \>= 1,000/microliter, Platelets \>= 100,000/microliter, Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), aspartate aminotransferase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) and serum glutamic pyruvic transaminase (SGPT) =\< 1.5 x institutional upper limit of normal (ULN). Exceptions to this Inclusion Criteria can be made if labs are deemed not clinically significant by the principal investigator (PI). 7. Willing to use adequate contraception, subject or partner has had a vasectomy or partner is using effective birth control or is post-menopausal for the duration of the study. 8. Able to take oral medication. 9. Able to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Pregnant women. 2. Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions. 3. Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks. 4. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness). 5. History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior. 6. Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years. 7. Subjects with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI. 8. History of allergic reactions attributed to compounds of similar chemical composition to Curcumin (turmeric). 9. Active or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension. Exceptions to this Exclusion Criteria can be made if patient status is deemed not clinically significant by the PI. 10. Severe thrombocytopenia increasing the risk of biopsy. 11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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