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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: Recruiting Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Presage Biosciences.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The localized activity of injected microdoses will be analyzed using the NanoString GeoMx Digital Spatial Profiler (DSP) and the GeoMx Cancer Transcriptome Atlas to comprehensively profile over 1800 genes simultaneously with spatial resolution to describe tumor biology, the TME, and the immune response signatures of each drug at an injection site. DSP outcomes may be validated via IHC, immunofluorescence, or ISH technique.

Conditions Studied

Head and Neck Squamous Cell Carcinoma

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

FieldValue
Enrollment Target 15 participants
Start Date 2024-05-22
Est. Completion 2025-04
Phase Early Phase 1
Presage Biosciences

8 total trials

What NCT06366451 shows while recruiting

NCT06366451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower).

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 lists 7 locations in 6 states (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.

Learn More About Clinical Trials

Similar trials for Head and Neck Squamous Cell Carcinoma

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 NCT06366451's enrollment target sits among peer trials

15 111th of 124 higher than 12 of 124 other Head and Neck Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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 NCT06366451

Source: ClinicalTrials.gov NCT06366451, the US trial registry maintained by the National Library of Medicine. NCT06366451 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.