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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2022
  • participants needed
    27
  • sponsor
    Hookipa Biotech GmbH
Updated on 11 February 2021

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.

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 who are candidates for transoral surgery. Participants will receive a single dose of the study agent HB-201 prior to transoral surgery. Arm 1 will consist of 2 Cohort groups; Cohort 1 will enroll subjects receiving HB-201 as an intratumoral injection and Cohort 2 will enroll patients receiving HB-201 administered intravenously.

In Arm 2, the study will enroll cervical cancer subjects who have locally advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype. Subjects with advanced/metastatic disease that are previously untreated who are planning to undergo upfront chemoradiation for local control are eligible and will receive an intratumoral injection of HB-201 prior to the start of chemoradiation.

Details
Condition HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
Treatment HB-201 IT, HB-201 IV
Clinical Study IdentifierNCT04630353
SponsorHookipa Biotech GmbH
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note