A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer

NCT04630353 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: H-200-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Approximately 6-8 weeks

Secondary Outcomes (6)

• Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.

  Approximately 6-8 weeks

• Investigate metabolic and proteomics changes in serum and plasma.

  Approximately 6-8 weeks

• Investigate the t-cell receptor repertoire diversity and clonality.

  Approximately 6-8 weeks

• Clinical evidence of response to HB-201

  Approximately 6-8 weeks

• Toxicity profile of HB-201

  Approximately 30 days post HB-201 administration

Study Arms (2)

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.

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.

Drug: HB-201 IV

Interventions

HB-201 IV DRUG

HB-201 given IV, one (1) time, on day 1.

HB-201 Intravenously on Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hookipa Biotech GmbH: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chief Medical Officer

  Hookipa Biotech GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 16, 2020
• Study Start: July 28, 2021
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: September 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)