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NCT05108870 · ClinicalTrials.gov registry record · Phase 1

TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers

A Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, sponsored by University of Chicago.

Recruiting
Registry status
Phase 1
Development phase
98
Enrollment target
1
Study location

NCT05108870: Recruiting Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, sponsored by University of Chicago.

NCT05108870 is a Phase 1 study of Head and Neck Cancer and Human Papilloma Virus that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 98 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05108870, a Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, is actively recruiting participants, sponsored by University of Chicago.

RECRUITING
Registry status
Phase 1
Development phase
98 participants
Enrollment target
1
Study location

Study Summary

Doctors leading this study hope to learn about the safety and effectiveness of combining medications HB-201 and HB-202 (also known as TheraT® vectors) with chemotherapy using carboplatin and paclitaxel in the beginning of the study (induction) and if combining these medications can increase tumor shrinkage after therapy and reduce the amount of radiotherapy and chemotherapy that will later be needed. In addition, the study is looking at ways to reduce side effects overall using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone. Your participation in this research will last about 2 years. HB-201 and HB-202 are experimental (meaning the US Food and Drug Administration (FDA) has not approved these drugs), and therefore they can only be given in a research study.

Primary Outcome

The phase 1 dose of HB-201 monotherapy and alternating HB-201 and 202 therapy in combination with chemotherapy in patients with HPV 16 head and neck cancer as assessed by data on reported dose-limiting toxicities (side effects) among participants. These side effects will be measures according to the Common Terminology Criteria for Adverse Events version 5

Conditions Studied

Head and Neck Cancer Human Papilloma Virus Hpv HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • DRUG HB-201
  • DRUG HB-202
  • PROCEDURE Transoral Robotic Surgery

Study Locations (1)

Illinois

  • University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2024-07-17
Est. Completion 2027-01-01
Phase Phase 1
University of Chicago

796 total trials

What NCT05108870 shows while recruiting

NCT05108870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (62% lower).

The record links to 4 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT05108870 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT05108870 about?

NCT05108870 is a clinical study titled "TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers". Doctors leading this study hope to learn about the safety and effectiveness of combining medications HB-201 and HB-202 (also known as TheraT® vectors) with chemotherapy using carboplatin and paclitaxel in the beginning of the study (induction) and if combining these medications can increase tumor sh...

What is the current status of trial NCT05108870?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2024-07-17. Estimated completion is 2027-01-01.

What conditions does trial NCT05108870 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Human Papilloma Virus, Hpv, HPV Positive Oropharyngeal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT05108870?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), HB-201 (DRUG), HB-202 (DRUG), Transoral Robotic Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT05108870?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05108870 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05108870's enrollment target sits among peer trials

98 87th of 250 higher than 162 of 250 other Head and Neck Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05108870

Source: ClinicalTrials.gov NCT05108870, the US trial registry maintained by the National Library of Medicine. NCT05108870 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.