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

A Pilot Study Evaluating HB-200 in Patients With Positive TTMV-HPV DNA After Definitive Treatment for HPV16 Positive HNSCC

NCT06373380•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically (histologically or cytologically) proven diagnosis of HPV16+ squamous cell carcinoma of the head and neck post standard of care definitive therapy.
•* History of histologically confirmed HPV16+ squamous cell cancer (from in-house or local evaluation by HPV16 RNA in situ hybridization (ISH) or PCR) is required for all patients on study.
•* Detection of HPV16 specific TTMV-HPV DNA via peripheral blood NavDx assay in combination with historically confirmed p16 expression can be used as a surrogate for enrollment and initiation of treatment as per the discretion of site PI whilst histological confirmation with RNA ISH or PCR is in process.
•No clinical or radiographic evidence of persistent or recurrent disease at time of evaluation (indeterminate findings are allowed based on discretion of P.I.)
•Positive TTMV-HPV DNA score (HPV16 specific) by NavDx® 3 months or more after definitive therapy for HPV16+ squamous cell carcinoma of the head and neck allows for pre-screen consent for a confirmatory NavDx.
•Definitive therapy includes surgery and/or chemotherapy/radiation therapeutic paradigms that are aimed at eradicating and curing disease with the goal of no additional therapies being required afterwards. This will include standard of care treatments and IRB-approved, de-escalation treatment protocols and strategies.For those patients who had surgery only as definitive therapy, a positive TTMV-HPV DNA score after completion of surgery fulfills this inclusion criterion. Enrollment of patients who had de-escalated treatment or nonstandard treatment paradigms, including salvage therapies, performed off an IRB-approved protocol/clinical trial will require the approval of the study P.I.
•Male or female patients 18 years of age or older on the day of consent.
•ECOG Performance Status of 0 to 1.
•Adequate hematologic function within 30 days prior to registration, defined as follows:
•* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
+26 more criteria

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
+11 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

April 15, 2024

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2027

Last Updated

January 20, 2026

Enrollment

ACTUAL participants

Conditions

HPV16+ Squamous Cell Carcinoma

Interventions

HB-200

DRUG