Evaluating APG-157 for treating head and neck cancer
Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx
This study is testing a new oral treatment called APG-157 to see if it can help shrink tumors in patients with newly diagnosed head and neck cancer before they have surgery or radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aveta Biomics, Inc. Industry-sponsored |
| Drugs / interventions | cetuximab, Chemotherapy, radiation |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05312710 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the safety and efficacy of APG-157, an orally administered pastille, as a neoadjuvant therapy for patients with newly diagnosed, locally advanced head and neck cancer, specifically squamous cell carcinoma of the oral cavity and oropharynx. Patients will receive APG-157 for four to six weeks before undergoing definitive treatment, such as surgery or radiation. The study aims to assess changes in tumor size and biomarkers to determine the drug's effectiveness in reducing tumor burden prior to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed, treatment-naive patients with Stage I to IV squamous cell carcinoma of the oral cavity or oropharynx.
Not a fit: Patients whose definitive treatment is scheduled to occur in less than four weeks from diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with head and neck cancer by reducing tumor size before definitive therapy.
How similar studies have performed: Other studies have shown promise with neoadjuvant therapies in head and neck cancer, but the specific use of APG-157 is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 1 other locations
- VAGLAHS, West Los Angeles — Los Angeles, California, United States (Recruiting)
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Marilene B Wang, MD — VA Los Angeles/UCLA
- Study coordinator: Marilene B Wang, MD
- Email: marilene.wang@va.gov
- Phone: 310 268-3748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.