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

Part of paid clinical trials in Miami, Florida.

Sponsor
Elizabeth J Franzmann
Study ID
NCT05865028
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APG-157 — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 24, 2023
Status verified
Dec 2025
Primary completion
May 24, 2027
Completion
May 24, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: APG-157 Therapy
    Participants will receive APG-157 for up to 12 weeks.

Primary Outcome Measure

Pathologic Response Rate [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Elizabeth J Franzmann, MD
[email protected]
+1 (305) 243-5955
Elizabeth J Franzmann, MD (PRINCIPAL_INVESTIGATOR)

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University of Miami· Miami, FL