Actively Recruiting
Phase II 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
52 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
Researchers are evaluating the effects of APG-157 in adults with oral dysplasia, including moderate to severe oral dysplasia or carcinoma in situ (CIS). The study aims to determine whether APG-157 can reduce tumor size and affect certain tumor markers and oral rinses in participants with these oral conditions. This is a Phase II proof of concept trial focused on the safety and efficacy of APG-157. Participants will receive oral APG-157 therapy, taking 200mg (two 100mg pastilles) three times daily during each 4-week cycle for up to three cycles, with the third cycle being optional. The treatment period lasts up to 12 weeks. The study will measure the pathologic response rate during this time and monitor clinical response, changes in lesion appearance, and treatment-related adverse events over a follow-up period extending up to 28 months. During the study, participants will undergo blood tests, oral rinses, and tissue biopsies for evaluation. Researchers will track tumor size and lesion changes through clinical and pathological assessments. Safety will be monitored by recording adverse events for up to 16 weeks. Participants will be involved for the full treatment period and follow-up visits as scheduled to assess outcomes and monitor health.
CONDITIONS
Brief 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 aged over 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ and a visible lesion
- Histologically confirmed oral cavity or oropharyngeal moderate or severe dysplasia/CIS diagnosed by standard pathology
- Measurable disease with a minimum lesion size of 8 x 3 mm before initial biopsy
- Willingness to provide blood, oral rinse, and tissue samples from diagnostic biopsies
- Leukocyte count of at least 3,000/microliter
- Absolute neutrophil count of at least 1,000/microliter, platelets at least 100,000/microliter, and liver enzymes within 1.5 times the institutional upper limit of normal, unless deemed not clinically significant by the principal investigator
- Willingness to use effective contraception, or partner has had a vasectomy, or partner is using effective birth control, or 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 previous 8 weeks, excluding biopsies and tooth extractions
- Fracture of the mandible or maxilla within the previous 8 weeks
- Inability to complete enrollment forms due to mental status or language problems
- History of prior head and neck squamous cell carcinomas unless curatively treated at least 1 year prior
- Use of chemotherapy or radiation for any malignancy (except nonmelanoma skin cancer or cancer treated only by organ removal) in the past 2 years
- Other significant related diseases of the oral cavity or oropharynx as determined by the principal investigator
- History of allergic reactions to compounds chemically similar to Curcumin (turmeric)
- Active or chronic liver disease, hepatitis, cirrhosis, or portal hypertension unless deemed not clinically significant by the principal investigator
- Severe thrombocytopenia increasing biopsy risk
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants take 200mg of APG-157 orally three times daily during each 4-week cycle for up to three cycles. Cycle three is optional.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
E
Elizabeth J Franzmann, MD
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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