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Brief Title: Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Official Title: A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors
Study ID: NCT04541108
Brief 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.
Detailed Description: CIVO is a research tool composed of a hand-held single-use sterile injector coupled with fluorescent tracking microspheres called CIVO GLO that mark the sites of drug microdose injection, enabling rapid assessment of multiple oncology drugs or drug combinations simultaneously within a patient's tumor. Tumor responses to cancer treatments are highly context-specific and often involve complex interactions between the anti-cancer therapy, genetically diverse tumor cells, and a heterogeneous TME. This complexity is rarely modeled accurately in preclinical translational models of cancer. By utilizing intratumoral microdose injections with CIVO in advance of scheduled surgical intervention, this study will evaluate anti-cancer therapies directly in patients each with their own unique tumor genomic profile, intact TME, and immune system functional status. Because the platform delivers microdose amounts of each test agent or combination directly into the patient's tumor tissue, hypotheses can be tested earlier in the drug development process, consistent with the goals of the 2006 FDA Exploratory IND Guidance for Industry. The CIVO device penetrates solid tumors and simultaneously delivers subtherapeutic microdoses of up to eight anti-cancer agents or combinations of anti-cancer agents co-injected with CIVO GLO into discrete regions of the tumor as drug columns. At the time of the planned surgical intervention (at least four hours to up to seven days after the CIVO microdose injection), the injected tumor tissue is then excised and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column. Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for analysis. This Phase 0 Master Protocol is aimed at distinguishing promising candidates earlier in the drug development process while also avoiding systemic toxicities associated with typical clinical exposures to these therapies.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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
Name: Study Director
Affiliation: Presage Biosciences
Role: STUDY_DIRECTOR