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

Completed · Phase 1/Phase 2

Conditions studied: HPV-Related Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04180215

Run by

Hookipa Biotech GmbH

People needed

198

Starts

2019-12-11

Expected to finish

2025-01-09

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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):
• Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
• 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.
• 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

Where it is running

• O'Neal Comprehensive Cancer Center at UAB — Birmingham, Alabama, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Arkansas for Medical Sciences, Cancer Institute, Clinical Trials Office — Fayetteville, Arkansas, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA (University of California, Los Angeles) — Los Angeles, California, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Medical School — Maywood, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Fairway, Kansas, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Grossman School of Medicine — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Perlmutter Cancer Center at NYU Langone Hospital-Long Island — New York, New York, United States
• Montefiore-Einstein Center for Cancer Care — The Bronx, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Greenville Hospital System University Medical Center (ITOR) — Greenville, South Carolina, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Virgina Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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