AzTrials
AzTrials

HPV-Related Squamous Cell CarcinomaPhase 1/2NCT04180215

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

A Phase 1/2 study testing HB-201 intravenous administration., HB-202 intravenous administration alternating with HB-201 intravenous administration. and HB-202 / HB-201 alternating intravenous administration + pembrolizumab. in people with HPV-Related Squamous Cell Carcinoma, run by Hookipa Biotech GmbH at 34 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HPV-Related Squamous Cell Carcinoma
What is being tested?
HB-201 intravenous administration., HB-202 intravenous administration alternating with HB-201 intravenous administration. and HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
34 sitesin 3 countries
Study dates
11 Dec 2019to 9 Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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):
  • Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
  • At least 1 non-irradiated measurable lesion documented through imaging.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
  • Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
  • Meeting requirements of exclusion criteria for Treatment Group 3

Trial locations and contacts

34 sites in 3 countries.

34 sites in 3 countries

United States26 sites

  • O'Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama, 35294

  • University of Virgina Health System

    Charlottesville, Virginia, 22908

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Kansas Medical Center

    Fairway, Kansas, 66205

  • University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office

    Fayetteville, Arkansas, 72205

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Greenville Hospital System University Medical Center (ITOR)

    Greenville, South Carolina, 29605

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA (University of California, Los Angeles)

    Los Angeles, California, 90095

  • Loyola University Medical School

    Maywood, Illinois, 60153

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • 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

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461

Other trials in United States

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Virgen Macarena

    Seville, 410009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Netherlands1 site

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081

Other trials in Netherlands

About this study

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

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.

Read the detailed description

HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people.

The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.

Being tested
HB-201 intravenous administration., HB-202 intravenous administration alternating with HB-201 intravenous administration., HB-201 intravenous administration + standard of care regimen including pembrolizumab., HB-202 / HB-201 alternating intravenous administration + pembrolizumab., HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Keywords
Vaccine, Gene Therapy, TheraT®, E7E6, HPV 16 E7E6, HNSCC, HPV 16+ head and neck squamous cell cancer, Oropharyngeal cancer, HPV16, HPV 16, Head and neck cancer, Carcinoma, Carcinoma, squamous cell, Squamous cell carcinoma of head and neck, Neoplasms, squamous cell, Head and neck neoplasms, Pembrolizumab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Head and Neck Neoplasms, Carcinoma, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB-201 intravenous administration.Drug

    Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

  • HB-202 intravenous administration alternating with HB-201 intravenous administration.Drug

    Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).

  • HB-201 intravenous administration + standard of care regimen including pembrolizumab.Drug

    Dose Expansion

  • HB-202 / HB-201 alternating intravenous administration + pembrolizumab.Drug

    Dose Expansion

  • HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.Drug

    Dose Expansion

  • HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)Drug

    Dose escalation; 10 patients

Study groups in NCT04180215
Study groupRoleWhat they receive
Ph I, Group 1 and Group 2ExperimentalPatients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
Receives: Drug: HB-201 intravenous administration.
Ph I, Group 3 and Group 4ExperimentalPatients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
Receives: Drug: HB-202 intravenous administration alternating with HB-201 intravenous administration.
Ph II, Group BExperimentalPatients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.
Receives: Drug: HB-201 intravenous administration + standard of care regimen including pembrolizumab.
Ph II, Group EExperimentalPatients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.
Receives: Drug: HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.
Ph II, Group FExperimentalPatients 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..
Receives: Drug: HB-202 / HB-201 alternating intravenous administration + pembrolizumab.
Ph I, sub-studyExperimentalPatients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy
Receives: Drug: HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From dosing until 21-28 days after first dose

  2. 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).

    Measured: Until progression, (estimated up to 30-months)

Secondary outcomes (4)

  1. Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).

    Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 by monitoring the type, frequency, and severity of AEs and SAEs by monitoring the type, frequency, and severity of AEs and SAEs.

    Measured: From informed consent through 30 days after last dose.

  2. Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.

    Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using RECIST and iRECIST

    Measured: Until progression, (estimated up to 30-months)

  3. Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity.

    Confirm duration of preliminary antitumor activity of dosage regimens of HB-201 and HB-202 alone of in combination with pembrolizumab, using RECIST and iRECIST

    Measured: Up to 30-months (until progression)

  4. Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).

    Assess the safety and tolerability of dosage regimens of HB-201 and HB-202 alone or in combination with pembrolizumab by monitoring the type, frequency, and severity of AEs and SAEs.

    Measured: From informed consent through 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start11 Dec 2019
  3. Primary completion9 Jan 2025
  4. Study completion9 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180215
Sponsor's protocol ID
H-200-001
Other IDs
2019-000907-34, 2019
Status last verified
Sep 2025
First submitted
20 Sep 2019
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HB-201 intravenous administration., HB-202 intravenous administration alternating with HB-201 intravenous administration. and HB-202 / HB-201 alternating intravenous administration + pembrolizumab. in people with HPV-Related Squamous Cell Carcinoma, run by Hookipa Biotech GmbH at 34 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities. (time frame: From dosing until 21-28 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04180215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in