A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorElizabeth J Franzmann
About this trial
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 criteria
Qualifiers
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.
Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam.
Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
Willing to provide blood, oral rinse and tissue from diagnostic biopsies
Disqualifiers
Pregnant women.
Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks.
Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Trial design
Treatments tested in this trial
- APG-157
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Elizabeth J Franzmann
Lead sponsor
University of Miami
Sponsor institution
Aveta Biomics, Inc.
Collaborator
Source ClinicalTrials.gov