TerminatedEarly Phase 1

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

Stopped: Sponsor decision.

United States10 participantsStarted 2021-07-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 functi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.

Timeframe: Approximately 6-8 weeks

Trial details

NCT IDNCT04630353

SponsorHookipa Biotech GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-28

View on ClinicalTrials.gov More HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.