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NCT06373380 · ClinicalTrials.gov registry record · Early Phase 1

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 Early Phase 1 study of HPV16+ Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.

Active
Registry status
Early Phase 1
Development phase
7
Enrollment target
7
Study locations

NCT06373380: Active Early Phase 1 study of HPV16+ Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.

NCT06373380 is a Early Phase 1 study of HPV16+ Squamous Cell Carcinoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06373380, a Early Phase 1 study of HPV16+ Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
7 participants
Enrollment target
7
Study locations

Study 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.

Primary Outcome

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

Interventions

  • DRUG HB-200

Study Locations (7)

New York

  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) - Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) - New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale

New Jersey

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2024-04-15
Est. Completion 2027-04
Phase Early Phase 1
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the registry record for NCT06373380 still lists

NCT06373380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).

The record links to 1 condition, with HPV16+ Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which HB-200 is the first listed.

NCT06373380 lists 7 locations in 2 states (New York, New Jersey).

Frequently Asked Questions

What is clinical trial NCT06373380 about?

NCT06373380 is a clinical study titled "A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)". 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 throu...

What is the current status of trial NCT06373380?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2024-04-15. Estimated completion is 2027-04.

What conditions does trial NCT06373380 study?

This clinical trial studies the following conditions: HPV16+ Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06373380?

The interventions under investigation include: HB-200 (DRUG).

Who is sponsoring clinical trial NCT06373380?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06373380 being conducted?

This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06373380's enrollment target sits among peer trials

7 1826th of 2000 higher than 156 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06373380, the US trial registry maintained by the National Library of Medicine. NCT06373380 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.