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Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Sponsor: Presage Biosciences
Summary
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.
Official title: A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2021-07-26
Completion Date
2031-12
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Rilvegostomig
Intratumoral microdose injection by the CIVO device.
Volrustomig
Intratumoral microdose injection by the CIVO device.
Sabestomig
Intratumoral microdose injection by the CIVO device.
Pembrolizumab
Intratumoral microdose injection by the CIVO device.
AZD9592
Intratumoral microdose injection by the CIVO device
AZD9592 + Rilvegostomig
Intratumoral microdose injection by the CIVO device
AZD9592 + Volrustomig
Intratumoral microdose injection by the CIVO device
AZD9592 + Sabestomig
Intratumoral microdose injection by the CIVO device
AZD9592 + Pembrolizumab
Intratumoral microdose injection by the CIVO device
Locations (9)
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
UC Health
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Charleston, South Carolina, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
University of Washington
Seattle, Washington, United States