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

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).

NCT Number	NCT07667296
Lead Sponsor	Aveta Biomics, Inc.
Conditions	Head and Neck Cancer, Head and Neck (HNSCC), Oropharyngeal, Oral Cavity, Oral Cavity Carcinoma, Oropharynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
Enrollment	826 participants
Start Date	2026-07
Primary Completion	2031-12 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-01