NCT06373380

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	HB-200	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).

Timeline

• Start date: 2024-04-15
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-04-18
• Last updated: 2026-01-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study