Actively Recruiting
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Led by Presage Biosciences · Updated on 2024-04-18
15
Participants Needed
12
Research Sites
540 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to comply with the study's visit and assessment schedule.
- Male or female 18 years of age or older at screening.
- Pathologic diagnosis of solid tumors as specified in the relevant substudy.
- Ability and willingness to provide written informed consent before any study-specific procedure.
- At least one surface-accessible lesion with viable tumor tissue planned for surgical intervention.
- Female patients who are postmenopausal for at least one year, surgically sterile, or agree to use highly effective contraception or abstain from heterosexual intercourse during the study.
- Male patients who agree to use effective barrier contraception or abstain from heterosexual intercourse during the study.
- Agreement to refrain from donating ova (females) or sperm (males) during study participation.
You will not qualify if you...
- Tumors near or involving critical structures where injection would pose undue risk.
- Female patients who are both lactating and breastfeeding.
- Female patients with a positive pregnancy test at screening.
- Any uncontrolled illness, serious medical or psychiatric condition, or circumstance that could interfere with study adherence or compromise objectives, as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71115
Actively Recruiting
4
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Withdrawn
7
UC Health
Cincinnati, Ohio, United States, 45229
Completed
8
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
Sarah Cannon Research Institute
Charleston, South Carolina, United States, 29406
Actively Recruiting
11
UT Health
Houston, Texas, United States, 77030
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
P
Presage Biosciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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