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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aveta Biomics, Inc.

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.