Actively Recruiting
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Led by Elizabeth J Franzmann · Updated on 2026-01-14
32
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
E
Elizabeth J Franzmann
Lead Sponsor
A
Aveta Biomics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.
CONDITIONS
Official Title
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age > 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ and a visible lesion
- Histologically confirmed moderate or severe oral cavity or oropharyngeal dysplasia or carcinoma in situ with a visible lesion on oral exam
- Measurable lesion size of at least 8 x 3 mm before initial biopsy
- Willingness to provide blood, oral rinse, and tissue samples from diagnostic biopsies
- Leukocyte count ≥ 3,000/microliter
- Absolute neutrophil count ≥ 1,000/microliter
- Platelet count ≥ 100,000/microliter
- Total bilirubin ≤ 1.5 times institutional upper limit of normal
- AST, SGOT, ALT, and SGPT ≤ 1.5 times institutional upper limit of normal (exceptions possible if deemed clinically insignificant by investigator)
- Willingness to use adequate contraception, or subject/partner has had a vasectomy, or partner is using effective birth control, or subject is post-menopausal during the study
- Ability to take oral medication
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Pregnant women
- Surgery of the oral cavity, teeth, or gums within the past 8 weeks (excluding biopsies and tooth extractions)
- Fracture of the mandible or maxilla within the past 8 weeks
- Inability to complete enrollment forms due to mental status or language problems (e.g., dementia, head injury)
- History of prior head and neck squamous cell carcinoma unless curatively treated at least 1 year prior
- Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and organ-confined cancers treated only by removal) in the past 2 years
- Other significant diseases of the oral cavity or oropharynx as determined by the investigator
- History of allergic reactions to compounds chemically similar to curcumin (turmeric)
- Active or chronic liver disease, hepatitis, cirrhosis, or portal hypertension (exceptions possible if deemed clinically insignificant by investigator)
- Severe thrombocytopenia increasing biopsy risk
- Uncontrolled illnesses including infection, heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
E
Elizabeth J Franzmann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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