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NCT07667296Not yet recruitingPhase 3

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

A Multicenter, Randomized, Open-Label Phase 3 Study of APG-157 as Neoadjuvant Therapy or as Induction and Maintenance Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
826 (estimated)
First submitted
8 Jun 2026
Start date
1 Jul 2026
Primary completion date
31 Dec 2031
Lead sponsor
Aveta Biomics, Inc.
NCT number
NCT07667296

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 826
  • From 1 Jul 2026 to the primary completion date, 31 Dec 2031
  • No sites listed in no 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

  • Prior solid organ or allogeneic stem cell transplant
  • Prior treatment for current head and neck squamous cell carcinoma.
  • Live vaccine within 30 days

Other illness

  • Stage I-II disease
  • Stage IVb or Ivc disease
  • T4b unresectable disease
  • N3 disease where applicable
  • Stage I-II disease
  • Disease not appropriate for curative-intent CRT
  • Active autoimmune disease requiring systemic therapy
  • Prior malignancy unless protocol exceptions met
  • Distant metastatic disease
  • Known hypersensitivity to APG-157 or its components.
  • Active uncontrolled infection
  • Significant uncontrolled cardiovascular disease
  • Any condition compromising safety, compliance, or study interpretation
    • Randomization ratio: 1:1 within each cohort
    • Stratification Factors:
    • Cohort A:

Lab values

  • QTcF \>500 msec or congenital long QT syndrome

Other

  • Cohort A Specific:
  • Medically eligible for perioperative pembrolizumab
    • Cohort B Specific:
  • Ongoing immunosuppression \>10 mg/day prednisone equivalent
    • Common Exclusion Criteria:
  • Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.
  • Unresolved clinically significant toxicity
  • Recent participation in another investigational study
  • Pregnancy or breastfeeding.
  • HPV/p16 status,
  • Planned platinum strategy,
  • PD-L1 CPS category
    • Cohort B:
  • HPV/p16 status
  • Planned platinum strategy
  • Geographic region.

Who the study is looking for

  • 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.
  • ECOG Performance Status ≤2.
  • Adequate organ function.
  • Contraception requirements met.
  • Ability to comply with study procedures.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.