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

Sponsor
Aveta Biomics, Inc.
Study ID
NCT07667296
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Head and Neck (HNSCC)
  • Head and Neck Cancer
  • Oral Cavity
  • Oral Cavity Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal
  • Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APG-157 — DRUG
    APG-157 is a first-in-class investigational drug product, formulated as 100 mg soft hydrogel pastille to dissolve in the mouth
  • Surgery — PROCEDURE
    Definitive Surgery
  • Radiation/Chemotherapy — RADIATION
    Protocol-specified risk-adapted postoperative radiotherapy, with concurrent platinum-based chemotherapy (e.g., cisplatin or carboplatin) administered when indicated based on pathological risk factors
  • Radiation/Chemotherapy — RADIATION
    Definitive radiotherapy with concurrent protocol-specified platinum-based chemotherapy.

Study Details

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 Dates

First listed
Jun 25, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2032

Study Design

Enrollment
826 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - APG-157
    APG-157 600 mg/day (200 mg orally three times daily)for 6 weeks prior to curative-intent surgery followed by protocol-directed adjuvant therapy.
  • Active Comparator: Cohort A - Control
    Standard-of-care surgery and adjuvant therapy; Participants undergo curative-intent surgery followed by protocol-directed adjuvant therapy
  • Experimental: Cohort B - APG-157
    APG-157 induction therapy and standard-of-care definitive chemoradiotherapy followed by APG-157 maintenance therapy. Participants receive APG-157 600 mg/day for 4 weeks (200 mg orally three times daily) prior to definitive chemoradiotherapy, followed by APG-157 maintenance therapy for up to 1 year
  • Active Comparator: Cohort B - Control
    Standard-of-Care Chemoradiotherapy. Participants receive definitive upfront chemoradiotherapy

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: From randomization until the first occurrence of a protocol-defined EFS event, death, withdrawal from study follow-up, or study completion, assessed for up to approximately 36 months. ]

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