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RECRUITING
NCT04541108
EARLY_PHASE1

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Sponsor: Presage Biosciences

View on ClinicalTrials.gov

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

2024-04-18

Healthy Volunteers

No

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

Pembrolizumab

Intratumoral microdose injection by the CIVO device.

Locations (12)

UC Davis

Sacramento, California, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

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

Wake Forest University Health Sciences

Winston-Salem, 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

UT Health

Houston, Texas, United States

University of Washington

Seattle, Washington, United States