PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC

Part of paid clinical trials in Sacramento, California.

Sponsor
Presage Biosciences
Study ID
NCT06366451
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rilvegostomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Volrustomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Sabestomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Pembrolizumab — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 + Rilvegostomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 + Volrustomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 + Sabestomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 + Pembrolizumab — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device.

Study Details

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.

Key Dates

Start date
May 22, 2024
Status verified
Jan 2025
Primary completion
Feb 28, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Rilvegostomig, Volrustomig, Sabestomig, AZD9592, Pembrolizumab
    HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, AZD9592, and pembrolizumab as single agents and AZD9592 drug combinations with the evaluated biologics.

Primary Outcome Measure

Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, AZD9592, or pembrolizumab as single agents or as AZD9592 drug combinations with the evaluated biologics [ Time Frame: 1 to 3 days after microdose injection ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UC DavisSacramentoCalifornia95817
Clinical Research Supervisor
Arnaud Bewley, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Research Coordinator
University of North CarolinaChapel HillNorth Carolina27599
Research Coordinator
Oregon Health & Science University (OHSU)PortlandOregon97239
Research Coordinator
University of PennsylvaniaPhiladelphiaPennsylvania19107
Research Coordinator
Medical University of South CarolinaCharlestonSouth Carolina29407
Research Coordinator
Sarah Cannon Medical CenterCharlestonSouth Carolina29406
Research Coordinator

Find similar trials in Sacramento, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UC Davis· Sacramento, CAMontefiore Medical Center· The Bronx, NYUniversity of North Carolina· Chapel Hill, NCOregon Health & Science University (OHSU)· Portland, ORUniversity of Pennsylvania· Philadelphia, PAMedical University of South Carolina· Charleston, SC

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