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Virus Therapy

HB-201 IV for Oropharyngeal and Cervical Cancer

Q: Is this trial still recruiting participants?

According to the data available on clinicaltrials.gov, this research is recruiting patients now. It was initially posted on July 28th 2021 and recently edited on November 18th 2022.

Q: What aim is this experiment attempting to achieve?

This clinical trial, projected to last 6-8 weeks, is assessing the immunological response between IV and IT administration of HB-201. Secondary goals include evaluating tumor mutational burden (TMB, MSI) in tissue samples using whole exome sequencing pre and post administration of HB-201; measuring TH1/TH2 proinflammatory cytokines (mesoscale multiplex discovery assay); and characterizing t-cell receptor repertoire diversity and clonality through t-cell receptor sequencing before &#x26; after administering HB-201.

Q: What is the scope of participation in this research study?

Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants with the first post on July 28th 2021 and last update at November 18th 2022. 27 patients are needed from 1 site for enrolment in the trial.

Phase < 1

Waitlist Available

Research Sponsored by Hookipa Biotech GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 days post hb-201 administration

Awards & highlights

Study Summary

This 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.

Who is the study for?

This trial is for adults with HPV16+ oropharynx cancer (stages I-III, resectable tumors) or advanced cervical cancer (stages IB to IVB), who have good kidney and liver function, no prior radiation in the target areas, and no recent immunosuppressive treatments. Participants must not be pregnant/breastfeeding, agree to use effective contraception, and should be free from other cancers for at least 2 years.Check my eligibility

What is being tested?

The study tests HB-201 administered intravenously in patients with newly diagnosed HPV16+ oropharynx or locally advanced cervical cancer. It aims to understand the immune effects of this treatment on these types of cancers before any standard therapy like surgery or chemoradiation begins.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with similar immunotherapy agents include flu-like symptoms such as fever and chills, fatigue, pain at injection site, allergic reactions, and potential impacts on organ functions which will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 days post hb-201 administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 days post hb-201 administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 days post hb-201 administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.

Clinical evidence of response to HB-201

Investigate metabolic and proteomics changes in serum and plasma.

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: HB-201 Intravenously on Day 1Experimental Treatment1 Intervention

Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.

Group II: HB-201 Intravenously 7 to 14 days before chemoradiationExperimental Treatment1 Intervention

Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Hookipa Biotech GmbHLead Sponsor

5 Previous Clinical Trials

458 Total Patients Enrolled

Chief Medical OfficerStudy DirectorHookipa Biotech GmbH

122 Previous Clinical Trials

21,514 Total Patients Enrolled

Media Library

HB-201 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04630353 — Phase < 1

Oropharynx Cancer and Cervical Cancer Research Study Groups: HB-201 Intravenously 7 to 14 days before chemoradiation, HB-201 Intravenously on Day 1

Oropharynx Cancer and Cervical Cancer Clinical Trial 2023: HB-201 Highlights & Side Effects. Trial Name: NCT04630353 — Phase < 1

HB-201 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630353 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still recruiting participants?

"According to the data available on clinicaltrials.gov, this research is recruiting patients now. It was initially posted on July 28th 2021 and recently edited on November 18th 2022."

Answered by AI

What aim is this experiment attempting to achieve?

"This clinical trial, projected to last 6-8 weeks, is assessing the immunological response between IV and IT administration of HB-201. Secondary goals include evaluating tumor mutational burden (TMB, MSI) in tissue samples using whole exome sequencing pre and post administration of HB-201; measuring TH1/TH2 proinflammatory cytokines (mesoscale multiplex discovery assay); and characterizing t-cell receptor repertoire diversity and clonality through t-cell receptor sequencing before & after administering HB-201."

Answered by AI

What is the scope of participation in this research study?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants with the first post on July 28th 2021 and last update at November 18th 2022. 27 patients are needed from 1 site for enrolment in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04630353.