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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 either by IT injection or by IV route.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hookipa Biotech; Hookipa Biotech GmbH

Criteria

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 (Arm 1 Cohorts 1 and 2)

• Newly diagnosed, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, determined to be resectable.

• AJCC v8.0 Tumor, Node, Metastasis (TNM) stage I-III, cT1- 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.

• Cohort 2 (intratumoral administration) only: must have a safe and accessible tumor lesion amenable for biopsy and IT administration.

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 and IT administration.

• 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 Cohorts 1 and 2)

• 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.