RecruitingPhase 2NCT05865028

A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

Sponsor

Elizabeth J Franzmann

Enrollment

32 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Oral Carcinoma in Situ Oropharyngeal Dysplasia Oral Cavity Dysplasia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called APG-157 for people with oral carcinoma in situ, oral cavity dysplasia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-157

Participants will take 200mg (2 x 100mg pastilles) of APG-157 therapy orally (PO) three times daily during each 4-week cycle for up to three cycles. Cycle three is optional.

Locations(1)

University of Miami

Miami, Florida, United States

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NCT05865028

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