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

NCT05865028 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Dysplasia
  • Oral Cavity Dysplasia
  • Oral Carcinoma in Situ

Interventions

DRUG

APG-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.

Sponsors & Collaborators

  • Aveta Biomics, Inc.

    collaborator INDUSTRY

  • Elizabeth J Franzmann

    lead OTHER

Principal Investigators

  • Elizabeth J Franzmann, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2027-05-24
Completion
2028-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865028 on ClinicalTrials.gov