Safety and Efficacy of APG-157 in Head and Neck Cancer

  • End date
    Apr 21, 2023
  • participants needed
  • sponsor
    Aveta Biomics, Inc.
Updated on 4 October 2022
squamous cell carcinoma
definitive treatment
oral cancer


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.


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.

  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.

Condition Head and Neck Cancer, Squamous Cell Carcinoma of Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
Treatment APG-157
Clinical Study IdentifierNCT05312710
SponsorAveta Biomics, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma
Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0
Patients who are scheduled to receive the following therapy after APG-157 treatment
Local Therapy with Curative Intent Surgery alone or surgery followed by radiation
Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab
Patients who refuse surgery or are unfit for any local therapy

Exclusion Criteria

Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent
Pregnant women
Prior Chemotherapy or radiation therapy within the last 8 weeks
Patients with recurrent or metastatic cancer
Tooth abscesses
Bleeding gums or cracked teeth
Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks
Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks
Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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