🏛️ Verified NIH Record • Updated 2026-01-15

A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (NCT06373380)

🔵 Active, Not Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The researchers are doing this study to find out if HB-202/HB-201 is a feasible treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (33 items) and avoid the listed exclusions (22 items).

Location: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients with radiographically evident or biopsy proven recurrent or metastatic squamous cell carcinoma of the head and neck. Equivocal radiographic findings will be subjected to review and approval by PI discretion
  • Patients with simultaneous primary cancers aside from HPV 16+ HNSCC is excluded unless otherwise approved by PI
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI
  • Prior systemic chemotherapy or immune checkpoint inhibitor therapy for incurable head and neck squamous cell carcinoma (drug therapies in the neoadjuvant and/or chemoradiation setting is allowed).
  • Severe, active co-morbidity defined as the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute infection requiring intravenous therapy at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defect
  • Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low dose prednisone (≤ 10 mg or equivalent). The following are exceptions to this criterion:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗