A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
Public ClinicalTrials.gov record NCT04180215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients With HPV 16+ Confirmed Cancers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 \& HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
Study identification
- NCT ID
- NCT04180215
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 198 participants
Conditions and interventions
Conditions
Interventions
- HB-201 intravenous administration. Drug
- HB-202 intravenous administration alternating with HB-201 intravenous administration. Drug
- HB-201 intravenous administration + standard of care regimen including pembrolizumab. Drug
- HB-202 / HB-201 alternating intravenous administration + pembrolizumab. Drug
- HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab. Drug
- HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2019 (Actual)
- Primary completion
- Jan 9, 2025 (Actual)
- Completion
- Jan 9, 2025 (Actual)
- Last update posted
- Sep 15, 2025
2019 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| O'Neal Comprehensive Cancer Center at UAB | Birmingham | Alabama | 35294 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office | Fayetteville | Arkansas | 72205 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA (University of California, Los Angeles) | Los Angeles | California | 90095 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical School | Maywood | Illinois | 60153 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Grossman School of Medicine | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Perlmutter Cancer Center at NYU Langone Hospital-Long Island | New York | New York | 11501 | — |
| Montefiore-Einstein Center for Cancer Care | The Bronx | New York | 10461 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Greenville Hospital System University Medical Center (ITOR) | Greenville | South Carolina | 29605 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Virgina Health System | Charlottesville | Virginia | 22908 | — |
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04180215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04180215 live on ClinicalTrials.gov.