Trials / Terminated
TerminatedNCT04630353
A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer
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
- Status
- Terminated
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Hookipa Biotech GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The window of opportunity, Study H-200-002, will examine the effects of study agent (HB-201) on subjects during the "window" between diagnosis of their cancer and their definitive cancer surgery or chemoradiation. The study will be a 2-arm study design. In Arm 1, the study will enroll subjects with resectable stage I-III human papillomavirus 16 positive (HPV 16+) genotype squamous cell cancer of the oropharynx or unknown primary cancer site who are candidates for transoral surgery. Participants will receive a single intravenous dose of the study agent HB-201 prior to transoral surgery administered intravenously. In Arm 2, the study will enroll cervical cancer subjects who have histologically confirmed newly diagnosed advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype clincal stages IB to IVB with plan for initial treatment of definitive chemoradiation. Participants will receive a single intravenous dose of HB-201 prior to the start of chemoradiation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HB-201 IV | HB-201 given IV, one (1) time, on day 1. |
| DRUG | HB-201 IV | HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation. |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2023-11-28
- Completion
- 2023-11-28
- First posted
- 2020-11-16
- Last updated
- 2025-09-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04630353. Inclusion in this directory is not an endorsement.