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

Who is this study for? Adult patients with HPV16-Positive Stage IB to IVB Cervical Cancer
What treatments are being studied? HB-201
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2021-07-28
Completion Date: 2023-11-28
Participants
Target number of participants: 10
Treatments
Experimental: HB-201 Intravenously on Day 1
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.
Experimental: HB-201 Intravenously 7 to 14 days before chemoradiation
Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.
Sponsors
Leads: Hookipa Biotech GmbH

This content was sourced from clinicaltrials.gov

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