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 Phase 1 FDA Drug

• 1 other identifier: 23-293
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

HPV16+ Squamous Cell Carcinoma

Keywords

HB-202/HB-201; Human Papilloma Virus; Head and Neck Squamous Cell Cancer; 23-293

Outcome Measures

Primary Outcomes (1)

• Evaluable for overall survival

  Patients who have received at least one dose of treatment will be considered evaluable. Origin time point will be from start of treatment.

  up to 3 years

Secondary Outcomes (1)

• Number of participants with adverse events (type, frequency, severity).

  1 year

Study Arms (1)

HB-200 arm

EXPERIMENTAL

HB-202 and HB-201 will be given in an alternating fashion for 4 total treatments.

Drug: HB-200

Interventions

HB-200 DRUG

HB-200 arm will receive HB-202 and HB-201 (HB-202: 1 x 10 \^7 RCV FFU and HB201: 5 x 106 RCV FFU) in an alternating fashion every (21 days) intravenously for 4 doses (2 doses each of HB-202 and HB-201 alternating).

HB-200 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 9.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable
• Adequate renal function within 30 days prior to registration, defined as follows:
• °Serum creatinine \< 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 30 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
• Adequate hepatic function within 30 days prior to registration, defined as follows:
• Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN.

You may not qualify if:

• 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:
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic treatment.
• Live vaccines within 28 days prior to the first dose of study treatment and while on study treatment, unless agreed otherwise between the Sponsor and Investigator.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Hookipa Biotech GmbH: collaborator
• Naveris: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Winston Wong, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single center study.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (7)