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

NCT ID: NCT05865028

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2028-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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Oropharyngeal Dysplasia Oral Cavity Dysplasia Oral Carcinoma in Situ

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APG-157 Therapy

Participants will receive APG-157 for up to 12 weeks.

Group Type EXPERIMENTAL

APG-157

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam.
3. Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
4. Willing to provide blood, oral rinse and tissue from diagnostic biopsies
5. Leukocytes \>=3,000/microliter
7. Willing to use adequate contraception, subject or partner has had a vasectomy or partner is using effective birth control or is post-menopausal for the duration of the study.
8. Able to take oral medication.
9. Able to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Pregnant women.
2. Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
3. Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks.
4. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
5. History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior.
6. Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years.
7. Subjects with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.
8. History of allergic reactions attributed to compounds of similar chemical composition to Curcumin (turmeric).
10. Severe thrombocytopenia increasing the risk of biopsy.
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aveta Biomics, Inc.

INDUSTRY

Sponsor Role collaborator

Elizabeth J Franzmann

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth J Franzmann

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elizabeth J Franzmann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2023-04230

Identifier Type: REGISTRY

Identifier Source: secondary_id

20221112

Identifier Type: -

Identifier Source: org_study_id