An Early Phase 1 interventional study of HB-201 IV and HB-201 IV in HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer, sponsored by AstraZeneca. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by AstraZeneca · Early Phase 1, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects:
HPV 16+ Oropharynx Cancer
HPV 16+ Cervical Cancer (Arm 2)
Exclusion Criteria:
All subjects:
HPV 16+ Oropharynx Cancer (Arm 1)
HPV 16+ Cervical Cancer (Arm 2)
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.
Drug: HB-201 IV
Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.
Drug: HB-201 IV
HB-201 given IV, one (1) time, on day 1.
HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation.
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).
Time frame: Approximately 6-8 weeks
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Pre and post administration of HB-201
Time frame: Approximately 6-8 weeks
Investigate metabolic and proteomics changes in serum and plasma.
Pre and post administration of HB-201
Time frame: Approximately 6-8 weeks
Investigate the T-cell receptor repertoire diversity and clonality.
Pre and post administration of HB-201.
Time frame: Approximately 6-8 weeks
Clinical evidence of response to HB-201
Change in tumor size per RECIST v1.1
Time frame: Approximately 6-8 weeks
Toxicity profile of HB-201
Number and type of adverse events per CTCAE v5.0
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
Plan to share: 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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