NCT05312710Active, not recruitingPhase 2
Safety and Efficacy of APG-157 in 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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 16 Mar 2022
- Start date
- 22 Apr 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Aveta Biomics, Inc.
- Diseases
- Head and neck cancer
- NCT number
- NCT05312710
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 22 Apr 2022 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior Chemotherapy or radiation therapy within the last 8 weeks.
- 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.
Other illness
- Patients with recurrent or metastatic cancer.
- Bleeding gums or cracked teeth.
- 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.
Other
- Pregnant women.
- Tooth abscesses.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VAGLAHS, West Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami - Sylvester Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.