HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer Clinical Trial
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
| Verified date | March 2024 |
| Source | Hookipa Biotech GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | November 28, 2023 |
| Est. primary completion date | November 28, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 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. - Must not have a known allergy to cisplatin, carboplatin, or compounds of similar biologic composition. Exclusion Criteria: 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. - Prior allogeneic bone marrow transplantation or prior solid organ transplantation. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Hookipa Biotech GmbH |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens. | Pre and post administration of HB-201 | Approximately 6-8 weeks | |
| Secondary | Investigate metabolic and proteomics changes in serum and plasma. | Pre and post administration of HB-201 | Approximately 6-8 weeks | |
| Secondary | Investigate the t-cell receptor repertoire diversity and clonality. | Pre and post administration of HB-201. | Approximately 6-8 weeks | |
| Secondary | Clinical evidence of response to HB-201 | Change in tumor size per RECIST v1.1 | Approximately 6-8 weeks | |
| Secondary | Toxicity profile of HB-201 | Number and type of adverse events per CTCAE v5.0 | Approximately 30 days post HB-201 administration | |
| Secondary | Other Exploratory Biomarker research may be conducted on any tumor tissue and/or blood samples collected during the study. | Approximately 6-8 weeks |