A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
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
2 other identifiers
interventional
198
3 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2019
Longer than P75 for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedStudy Start
First participant enrolled
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2025
CompletedSeptember 15, 2025
September 1, 2025
5.1 years
September 20, 2019
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
Determine the recommended Phase II dose in terms of safety and tolerability for intravenously administered HB-201, and intravenously administered HB-202 by assessing drug limiting toxicities.
From dosing until 21-28 days after first dose
Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.
Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using Response Evaluation Criteria in Solid Tumors (RECIST) to determine objective response rate (ORR).
Until progression, (estimated up to 30-months)
Secondary Outcomes (4)
Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).
From informed consent through 30 days after last dose.
Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.
Until progression, (estimated up to 30-months)
Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity.
Up to 30-months (until progression)
Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).
From informed consent through 30 days after last dose
Study Arms (6)
Ph I, Group 1 and Group 2
EXPERIMENTALPatients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
Ph I, Group 3 and Group 4
EXPERIMENTALPatients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
Ph II, Group B
EXPERIMENTALPatients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.
Ph II, Group E
EXPERIMENTALPatients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.
Ph II, Group F
EXPERIMENTALPatients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care..
Ph I, sub-study
EXPERIMENTALPatients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy
Interventions
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
Dose Expansion
Dose Expansion
Dose Expansion
Dose escalation; 10 patients
Eligibility Criteria
You may qualify if:
- All Patients:
- Documentation of confirmed HPV 16+ cancer via genotype testing.
- ≥ 1 measurable lesion by imaging for tumor response following RECIST
- ECOG performance status of 0 to 1.
- Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
- Screening laboratory values must meet protocol-specified criteria.
- Able to provide tumor tissue following last treatment, unless otherwise agreed.
- Treatment Group E or Group F:
- Documentation of confirmed head and neck squamous cell carcinoma.
- Eligible to receive pembrolizumab, per standard of care and product label.
- Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
- Group F: Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy.
- Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
- At least 1 non-irradiated measurable lesion documented through imaging.
You may not qualify if:
- All patients:
- Metastatic central nervous system disease, and/or carcinomatous meningitis.
- Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
- Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met.
- Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
- Has a life expectancy of less than 3 months.
- Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
- Not meeting the protocol-specified washout periods for prohibited medications.
- Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
- Known history of acquired immunodeficiency syndrome.
- For patients in Groups E or F and certain backfill cohorts:
- History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
- History of/Presently having non-infectious pneumonitis requiring treatment.
- Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office
Fayetteville, Arkansas, 72205, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA (University of California, Los Angeles)
Los Angeles, California, 90095, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Loyola University Medical School
Maywood, Illinois, 60153, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Fairway, Kansas, 66205, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Grossman School of Medicine
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Perlmutter Cancer Center at NYU Langone Hospital-Long Island
New York, New York, 11501, United States
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, 10461, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, 29605, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Virgina Health System
Charlottesville, Virginia, 22908, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Amsterdam UMC, Locatie VUMC
Amsterdam, 1081, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Universitario Virgen Macarena
Seville, 410009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Head of Clinical Development
Hookipa Biotech GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2019
First Posted
November 27, 2019
Study Start
December 11, 2019
Primary Completion
January 9, 2025
Study Completion
January 9, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share