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

NCT06366451 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-20

No results posted yet for this 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

Interventions

BIOLOGICAL

Rilvegostomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Volrustomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Sabestomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

AZD9592

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Pembrolizumab

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

AZD9592 + Rilvegostomig

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

AZD9592 + Volrustomig

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

AZD9592 + Sabestomig

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

AZD9592 + Pembrolizumab

Intratumoral microdose injection by the CIVO device.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Study Director · Presage Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2025-02-28
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366451 on ClinicalTrials.gov