Actively Recruiting
Phase 2 Study of APG-157 Oral Therapy for Treating Moderate to Severe Oral and Oropharyngeal Dysplasia
Led by Elizabeth J Franzmann · Updated on 2026-01-14
32
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Research Team
E
Elizabeth J Franzmann, MD
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