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

Launched by AVETA BIOMICS, INC. · Mar 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called APG-157 to see if it is safe and effective for patients with head and neck cancer, specifically types of cancer affecting the oral cavity and oropharynx. The goal is to give this medication before starting other treatments, like surgery or radiation, to help shrink the tumors and improve treatment outcomes compared to standard care. The trial is currently looking for participants aged 65 and older who have been newly diagnosed with certain stages of squamous cell carcinoma in these areas.

To be eligible, patients must have a confirmed diagnosis and be scheduled for further treatment after the trial, such as surgery or radiation therapy. However, those who have had recent surgeries or treatments, are pregnant, or have certain dental issues will not qualify. Participants in this trial can expect to take APG-157 orally and will be monitored for safety and effectiveness throughout the study. This trial may offer a new treatment option for patients facing a challenging diagnosis, and it aims to improve the overall care they receive.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A. Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma.
• • B. 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.
• • C. Patients who are scheduled to receive the following therapy after APG-157 treatment.
• • 1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.
• • 2. 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.
• • 3. Patients who refuse surgery or are unfit for any local therapy.
• Exclusion Criteria:
• • A. 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.
• • B. Pregnant women.
• • C. Prior Chemotherapy or radiation therapy within the last 8 weeks.
• • D. Patients with recurrent or metastatic cancer.
• • E. Tooth abscesses.
• • F. Bleeding gums or cracked teeth.
• • G. Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks.
• • H. Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks.
• • I. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
• • J. Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.