RecruitingEarly Phase 1NCT04541108

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

A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors


Sponsor

Presage Biosciences

Enrollment

15 participants

Start Date

Jul 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a device called CIVO to inject tiny (microdose) amounts of multiple anti-cancer drugs directly into a tumor at once, allowing doctors to see which drug works best in that specific tumor — all before the patient starts full systemic treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed solid tumor diagnosis (specific tumor types are listed in each sub-study) - You have at least one tumor that is accessible on the surface of the skin or in a lymph node - You are willing and able to complete study visits and procedures **You may NOT be eligible if...** - Your tumor cannot be safely accessed for injection - You have serious health conditions that prevent participation - You are unable or unwilling to provide written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRilvegostomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICALVolrustomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICALSabestomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICALPembrolizumab

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

View Full Details on ClinicalTrials.gov

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NCT04541108


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