APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma

Starting soon · Phase 3

Conditions studied: Head and Neck Cancer, Head and Neck (HNSCC), Oropharyngeal, Oral Cavity, Oral Cavity Carcinoma, Oropharynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma

In brief

This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Two independently powered cohorts are enrolled based on treatment pathway. Cohort A evaluates APG-157 administered as neoadjuvant therapy before curative-intent surgery in participants with resectable oral cavity or oropharyngeal cancer who are medically ineligible for perioperative pembrolizumab. Cohort B evaluates APG-157 administered as induction therapy before definitive chemoradiotherapy and as maintenance therapy after chemoradiotherapy in participants with unresectable or medically inoperable disease. Participants are randomized 1:1 within each cohort to receive APG-157-based treatment or standard-of-care therapy. The primary hypothesis is that APG-157 given before definitive surgery followed by (chemo)radiotherapy improves event-free survival (EFS) compared to surgery and adjuvant (chemo)radiotherapy alone (Cohort A), and that APG-157 given as induction therapy prior to definitive chemoradiotherapy (CRT) followed by maintenance APG-157 improves EFS compared to definitive CRT alone (Cohort B).

Key facts

Study ID

NCT07667296

Run by

Aveta Biomics, Inc.

People needed

826

Starts

2026-07-01

Expected to finish

2032-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort A (Resectable Disease)
• Adults ≥18 years
• Histologically or cytologically confirmed, previously untreated locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity or oropharynx.
• Resectable disease appropriate for curative-intent surgery.
• Stage III-IVA disease according to AJCC criteria:
• Oropharynx, p16-positive: Stage III (T4, N0-N3, M0)
• Oropharynx, p16-negative: Stage III or IVa (T3-T4, N0-N2, M0)
• Oral cavity: Stage III or IVa (T3-T4, N0-N2, M0)
• Objectively medically ineligible for perioperative pembrolizumab according to protocol-defined objective criteria.
• HPV/p16 testing available for stratification.
• Measurable or evaluable disease.
• Life expectancy ≥12 months.
• ECOG Performance Status ≤2.
• Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
• Ability to comply with study procedures.
• Cohort B (Unresectable / Medically Inoperable Disease)
• Adults ≥18 years
• Histologically or cytologically confirmed, previously untreated LA-HNSCC of the oropharynx. Disease not suitable for curative-intent surgery.
• Stage III-IVA disease according to AJCC criteria:
• p16-positive Stage III (T4, N0-N3, M0) with >10 pack-year smoking history
• p16-negative Stage III or IVa (T3-T4, N0-N2, M0)
• HPV/p16 testing available for stratification.
• Presence of evaluable tumor burden.
• Eligible to receive definitive chemoradiotherapy.
• Life expectancy ≥12 months.

You may not qualify if…

• Cohort A Specific:
• Stage I-II disease
• Stage IVb or Ivc disease
• T4b unresectable disease
• N3 disease where applicable
• Medically eligible for perioperative pembrolizumab
• Cohort B Specific:
• Stage I-II disease
• Disease not appropriate for curative-intent CRT
• Active autoimmune disease requiring systemic therapy
• Prior solid organ or allogeneic stem cell transplant
• Ongoing immunosuppression >10 mg/day prednisone equivalent
• Common Exclusion Criteria:
• Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.
• Prior treatment for current head and neck squamous cell carcinoma.
• Prior malignancy unless protocol exceptions met
• Distant metastatic disease
• Live vaccine within 30 days
• Known hypersensitivity to APG-157 or its components.
• Unresolved clinically significant toxicity
• Recent participation in another investigational study
• Active uncontrolled infection
• Significant uncontrolled cardiovascular disease
• Pregnancy or breastfeeding.
• QTcF >500 msec or congenital long QT syndrome

Full record on ClinicalTrials.gov

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