HPV 16+ Confirmed Oropharynx Cancer and Cervical CancerEarly Phase 1NCT04630353
A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer
A Early Phase 1 study testing HB-201 IV in people with HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer, run by AstraZeneca at 1 site in United States.
Trial summary
This Window of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered by IV route. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
- What is being tested?
- HB-201 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 28 Nov 2023
- Phase
- Early Phase 1
- 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 subjects:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Confirmed HPV 16+ (human papilloma virus 16 positive) genotype testing of cancer.
- Disease-free for ≥ 2 years from other curatively treated cancers, with protocol-defined exceptions.
- Evaluated by cardiologist and/or neurologist if protocol-defined cardiac or neurological event within the last 6 months.
- HPV 16+ Oropharynx Cancer
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- Newly diagnosed, head and neck squamous cell carcinoma or undifferentiated carcinoma of the oropharynx origin or unknown primary cancer site, determined to be resectable.
- AJCC v8.0 Tumor, Node, Metastasis (TNM) stage I-III, cT0- T3, and cervical nodes N1-N3 based on clinical or radiographic criteria with no evidence of distant metastases.
- No prior radiation above the clavicles.
- Must have acceptable renal and hepatic function as defined per protocol.
- HPV 16+ Cervical Cancer (Arm 2)
- Newly diagnosed, histologically confirmed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma): International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation (platinum agent weekly with radiotherapy) for either curative intent or control of local (pelvic) disease.
- No prior radiation to the abdomen or pelvis.
- Must have a safe and accessible tumor lesion amenable for biopsy.
- Must have normal organ and marrow function as defined per protocol.
- Must not have a known allergy to cisplatin, carboplatin, or compounds of similar biologic composition.
Who cannot join
- All subjects:
- Treatment with any systemic anticancer therapy within 3 years (unless agreed otherwise between the Sponsor and the Investigator).
- Treatment with any chronic immunosuppressive medication within 6 months (unless agreed otherwise between the Sponsor and Investigator).
- Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension.
- Live vaccine within 28 days (unless agreed otherwise between Sponsor and Investigator).
- Known diagnosis of acquired immunodeficiency syndrome (AIDS).
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- Positive Hepatitis B or Hepatitis C tests indicating acute or chronic infection.
- Intercurrent illness likely to interfere with protocol therapy.
- Female subjects who are pregnant or breastfeeding.
- Female subjects of childbearing potential who do not agree to the use of highly effective contraception per protocol.
- Male subjects with sexual partners of childbearing potential who do not agree to the use of protocol-defined contraception
- HPV 16+ Oropharynx Cancer (Arm 1)
- Primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine.
- HPV 16+ Cervical Cancer (Arm 2)
- Treatment with chemotherapy for cervical cancer, prior to planned chemoradiation.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase 0 Trial of HB-201 for Subjects With Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or With Locally Advanced Cervical Cancer Treated With Chemotherapy and Radiation
This Window of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered by IV route.
Read the detailed description
The window of opportunity, Study H-200-002, will examine the effects of study agent (HB-201) on subjects during the "window" between diagnosis of their cancer and their definitive cancer surgery or chemoradiation.
The study will be a 2-arm study design. In Arm 1, the study will enroll subjects with resectable stage I-III human papillomavirus 16 positive (HPV 16+) genotype squamous cell cancer of the oropharynx or unknown primary cancer site who are candidates for transoral surgery. Participants will receive a single intravenous dose of the study agent HB-201 prior to transoral surgery administered intravenously.
In Arm 2, the study will enroll cervical cancer subjects who have histologically confirmed newly diagnosed advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype clincal stages IB to IVB with plan for initial treatment of definitive chemoradiation. Participants will receive a single intravenous dose of HB-201 prior to the start of chemoradiation.
- Being tested
- HB-201 IV
- Keywords
- HPV, Oropharynx Cancer, Cervical Cancer, Intravenous, Lymphocytic Choriomeningitis Virus, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Transoral Surgery, Window of Opportunity, HPV 16+ cervical cancer, HPV 16+ head and neck squamous cell cancer, HPV 16 E7E6, E7E6
- Medical subject headings
- Uterine Cervical Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-201 IVDrug
HB-201 given IV, one (1) time, on day 1.
HB-201 IVDrug
HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation.
| Study group | Role | What they receive |
|---|---|---|
| HB-201 Intravenously on Day 1 | Experimental | Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site. Receives: Drug: HB-201 IV |
| HB-201 Intravenously 7 to 14 days before chemoradiation | Experimental | Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation. Receives: Drug: HB-201 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.
Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).
Measured: Approximately 6-8 weeks
Secondary outcomes (6)
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Pre and post administration of HB-201
Measured: Approximately 6-8 weeks
Investigate metabolic and proteomics changes in serum and plasma.
Pre and post administration of HB-201
Measured: Approximately 6-8 weeks
Investigate the T-cell receptor repertoire diversity and clonality.
Pre and post administration of HB-201.
Measured: Approximately 6-8 weeks
Clinical evidence of response to HB-201
Change in tumor size per RECIST v1.1
Measured: Approximately 6-8 weeks
Toxicity profile of HB-201
Number and type of adverse events per CTCAE v5.0
Measured: Approximately 30 days post HB-201 administration
Other Exploratory Biomarker research may be conducted on any tumor tissue and/or blood samples collected during the study.
Measured: Approximately 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start21 Jul 2021
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV 16+ Confirmed Oropharynx Cancer and Cervical CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hookipa Biotech GmbH
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Hookipa Biotech GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630353
- Sponsor's protocol ID
- H-200-002
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Trial of HB-201 for Subjects With Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or With Locally Advanced Cervical Cancer Treated With Chemotherapy and Radiation
- ClinicalTrials.gov ID
- NCT04630353
- Acronym / sponsor ID
- H-200-002
- Keywords
- HPV, Oropharynx Cancer, Cervical Cancer, Intravenous, Lymphocytic Choriomeningitis Virus, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Transoral Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hookipa Biotech GmbH
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Window of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered by IV route.
Detailed description
The window of opportunity, Study H-200-002, will examine the effects of study agent (HB-201) on subjects during the "window" between diagnosis of their cancer and their definitive cancer surgery or chemoradiation.
The study will be a 2-arm study design. In Arm 1, the study will enroll subjects with resectable stage I-III human papillomavirus 16 positive (HPV 16+) genotype squamous cell cancer of the oropharynx or unknown primary cancer site who are candidates for transoral surgery. Participants will receive a single intravenous dose of the study agent HB-201 prior to transoral surgery administered intravenously.
In Arm 2, the study will enroll cervical cancer subjects who have histologically confirmed newly diagnosed advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype clincal stages IB to IVB with plan for initial treatment of definitive chemoradiation. Participants will receive a single intravenous dose of HB-201 prior to the start of chemoradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB-201 Intravenously on Day 1 | Experimental | Drug: HB-201 IVPatients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site. |
| HB-201 Intravenously 7 to 14 days before chemoradiation | Experimental | Drug: HB-201 IVPatients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Confirmed HPV 16+ (human papilloma virus 16 positive) genotype testing of cancer.
- Disease-free for ≥ 2 years from other curatively treated cancers, with protocol-defined exceptions.
- Evaluated by cardiologist and/or neurologist if protocol-defined cardiac or neurological event within the last 6 months.
- HPV 16+ Oropharynx Cancer
Key exclusion criteria (16 listed)
- Treatment with any systemic anticancer therapy within 3 years (unless agreed otherwise between the Sponsor and the Investigator).
- Treatment with any chronic immunosuppressive medication within 6 months (unless agreed otherwise between the Sponsor and Investigator).
- Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension.
- Live vaccine within 28 days (unless agreed otherwise between Sponsor and Investigator).
- Known diagnosis of acquired immunodeficiency syndrome (AIDS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-201 IVHB-201 given IV, one (1) time, on day 1. | Drug | HB-201 Intravenously on Day 1 |
| HB-201 IVHB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation. | Drug | HB-201 Intravenously 7 to 14 days before chemoradiation |
Primary outcome
Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.
Time frame: Approximately 6-8 weeks
Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).
6 secondary outcomes
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Time frame: Approximately 6-8 weeks
Investigate metabolic and proteomics changes in serum and plasma.
Time frame: Approximately 6-8 weeks
Investigate the T-cell receptor repertoire diversity and clonality.
Time frame: Approximately 6-8 weeks
Clinical evidence of response to HB-201
Time frame: Approximately 6-8 weeks
Toxicity profile of HB-201
Time frame: Approximately 30 days post HB-201 administration
Other Exploratory Biomarker research may be conducted on any tumor tissue and/or blood samples collected during the study.
Time frame: Approximately 6-8 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Hookipa Biotech GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HB-201 IV in people with HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer, run by AstraZeneca at 1 site in United States.
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 16 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Sponsor decision.). Results are not available in the source record.
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?
Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer. (time frame: Approximately 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.