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NCT06366451 · ClinicalTrials.gov registry record · Early Phase 1
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
A Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Presage Biosciences.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 7
- Study locations
NCT06366451 is a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Presage Biosciences. The registered enrollment target is 15 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 6 states.
The verdict
NCT06366451, a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Presage Biosciences.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents, either as single agents or as AZD9592 drug combinations with the evaluated biologics, will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Volrustomig
- BIOLOGICAL Rilvegostomig
- BIOLOGICAL Sabestomig
- BIOLOGICAL AZD9592
Study Locations (7)
South Carolina
- Sarah Cannon Medical Center - Charleston
- Medical University of South Carolina - Charleston
California
- UC Davis - Sacramento
New York
- Montefiore Medical Center - The Bronx
North Carolina
- University of North Carolina - Chapel Hill
Oregon
- Oregon Health & Science University (OHSU) - Portland
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-22 |
| Est. Completion | 2025-04 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06366451
The ClinicalTrials.gov registry entry for NCT06366451 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower). The listed sponsor is Presage Biosciences, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06366451 reports 7 study locations spanning 6 distinct geographic areas - top geographies include South Carolina, California, New York.
Frequently Asked Questions
What is clinical trial NCT06366451 about?
NCT06366451 is a clinical study titled "PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC". This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presen...
What is the current status of trial NCT06366451?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2024-05-22. Estimated completion is 2025-04.
What conditions does trial NCT06366451 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06366451?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Volrustomig (BIOLOGICAL), Rilvegostomig (BIOLOGICAL), Sabestomig (BIOLOGICAL), AZD9592 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06366451?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06366451 being conducted?
This trial has 7 study locations across California, New York, North Carolina, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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