Study on the Safety and Effectiveness of APG-157 for Head and Neck Cancer

Sponsor: Aveta Biomics, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05312710

Provider View

This clinical trial is testing a new oral medication, APG-157, to see if it can safely and effectively reduce tumors in patients with newly diagnosed, locally advanced head and neck cancer before they undergo surgery or other treatments.

Patient Parameters

Program Overview

The aim of this study is to evaluate if taking APG-157, a new oral medication, can safely and effectively reduce the size of tumors in patients with newly diagnosed, locally advanced head and neck cancer. The medication is taken as a soft lozenge that dissolves in the mouth, three times a day, for four to six weeks before any major treatment like surgery or radiation. Researchers hope that by reducing the tumor size beforehand, the outcomes of the main treatment will improve.

Description

In this study, patients will take APG-157, a new oral medication, as a neoadjuvant treatment, which means it is given before the main treatment like surgery or radiation. APG-157 comes in the form of a soft lozenge that dissolves in the mouth and is taken three times a day. The treatment lasts for four weeks but can be extended to six weeks if both the patient and the researchers agree.

The main goals of the study are:

  1. To see how APG-157 affects the size of the tumor and certain markers in the tumor tissue in patients with head and neck cancer.
  2. To evaluate how well each patient responds to APG-157 based on their specific cancer diagnosis and planned treatment.
  3. To use the results to plan a future study that will further test the effectiveness of APG-157 in a larger group of patients.

After completing the APG-157 treatment, patients will proceed with their planned surgery or other definitive treatments, which may include radiation therapy, as decided by their doctor.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of squamous cell carcinoma in the oral cavity or oropharynx.
  • Be newly diagnosed and have not received any treatment for head and neck cancer.
  • Be in Stage I, II, III, or IV of head and neck squamous cell carcinoma (HNSCC) according to the UICC classification.
  • Be scheduled to receive one of the following treatments after APG-157:
    • Surgery with the intent to cure, either alone or followed by radiation.
    • Radiation alone with the intent to relieve symptoms, possibly with certain chemotherapy drugs.
    • Patients who refuse surgery or are not fit for local therapy.

Exclusion Criteria

  • Patients whose main treatment is scheduled to start in less than four weeks from diagnosis.
  • Pregnant women.
  • Patients who have had chemotherapy or radiation therapy in the last 8 weeks.
  • Patients with cancer that has returned or spread to other parts of the body.
  • Patients with dental issues like tooth abscesses, bleeding gums, or cracked teeth.
  • Patients who have had recent surgery or fractures in the mouth or jaw.
  • Patients unable to complete forms due to mental or language difficulties.
  • Patients with other significant diseases of the mouth or throat as determined by the study doctor.

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