A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcin… (NCT04180215) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
United States, Netherlands, Spain198 participantsStarted 2019-12-11
Plain-language summary
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 \& HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
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 Patients:
* Documentation of confirmed HPV 16+ cancer via genotype testing.
* ≥ 1 measurable lesion by imaging for tumor response following RECIST
* ECOG performance status of 0 to 1.
* Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
* Screening laboratory values must meet protocol-specified criteria.
* Able to provide tumor tissue following last treatment, unless otherwise agreed.
Treatment Group E or Group F:
* Documentation of confirmed head and neck squamous cell carcinoma.
* Eligible to receive pembrolizumab, per standard of care and product label.
* Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
* Group F: Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy.
Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
* Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
* At least 1 non-irradiated measurable lesion documented through imaging.
Exclusion Criteria:
All patients:
* Metastatic central nervous system disease, and/or carcinomatous meningitis.
* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
* Concurrent malignancy that is clinically significant or requires active inter…
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
1
Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
Timeframe: From dosing until 21-28 days after first dose
2
Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.
Timeframe: Until progression, (estimated up to 30-months)