Experimental immune drug tested in HPV cancers – but trial halted early
NCT ID NCT04630353
First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This very early trial tested a single dose of HB-201 in 10 people with HPV 16+ throat or cervical cancer. The goal was to see how the drug affects the immune system, not to treat the cancer. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HB-201
- What this could lead to
- If successful, this could help researchers understand how to boost the immune system against HPV-related cancers.
- What could go wrong
- This was a very early, small trial that was terminated, so results are limited. It is not a treatment study and may not lead to any new therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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10 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Nov 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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) • 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States