The purpose of this clinical research study is to study safety and efficacy of orally
administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally
advanced patients with Head & Neck Cancer of oral cavity and/or oropharynx.
The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden
prior to any definitive therapy to improve the outcomes over current standard of care.
Additional locations may be listed on ClinicalTrials.gov for NCT05312710.
See trial information on ClinicalTrials.gov for a list of participating sites.
The patient will receive neoadjuvant therapy (APG-157) during the period between initial
diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a
form of pastille (soft lozenge) taken three times a day. It dissolves in the mouth. After
the neoadjuvant treatment, the patient undergoes surgery or any other definitive therapy
and/or postoperative radiotherapy as determined by the patient's doctor. Duration of
treatment is four weeks that may be extended up to six weeks by mutual consent of the
patients and the investigators.
Objectives:
1. To conduct Phase 2A to determine how tumor size, tumor tissue biomarkers, and the
cancer stem cell markers, in head and neck squamous cell cancer patients are
affected by the administration APG-157 pastilles using imaging and other clinical
measurements.
2. To determine the degrees of response of each patient to APG-157 (considering
patient's diagnosis/staging and local treatment) using proposed primary, secondary
and exploratory endpoints.
3. The results from this study will be used to finalize the design of subsequent Phase
2B study (single arm for specific patient population and local treatment) to
demonstrate statistically significant efficacy outcomes.
Lead OrganizationAveta Biomics, Inc.
