For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria

All Patients:

  1. Documentation of confirmed HPV 16+ cancer via genotype testing.
  2. ≥ 1 measurable lesion by imaging for tumor response following RECIST
  3. ECOG performance status of 0 to 1.
  4. Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
  5. Screening laboratory values must meet protocol-specified criteria.
  6. Able to provide tumor tissue following last treatment, unless otherwise agreed.

Treatment Group E or Group F:

  1. Documentation of confirmed head and neck squamous cell carcinoma.
  2. Eligible to receive pembrolizumab, per standard of care and product label.
  3. Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
  4. 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.

    Exclusion Criteria:

    All patients:

    1. Metastatic central nervous system disease, and/or carcinomatous meningitis.
    2. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
    3. Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met.
    4. Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
    5. Has a life expectancy of less than 3 months.
    6. 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.
    7. Not meeting the protocol-specified washout periods for prohibited medications.
    8. Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
    9. Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
    10. Known history of acquired immunodeficiency syndrome.

    For patients in Groups E or F and certain backfill cohorts:

    1. History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
    2. History of/Presently having non-infectious pneumonitis requiring treatment.
    3. 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):

    1. Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
    2. Meeting requirements of exclusion criteria for Treatment Group 3

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply

    Contact the study center to learn if this study is a good match for you.

    Study’s details


    HPV-Related Squamous Cell Carcinoma

    Age (in years)



    Phase 1/Phase 2

    Participants needed


    Est. Completion Date

    Jun 30, 2025

    Treatment type



    Hookipa Biotech GmbH identifier


    Study number


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