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Clinical Trial Summary

This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.


Clinical Trial 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. In this Phase 0 intratumoral microdosing study in human patients with localized or metastatic primary HNSCC, STS, or TNBC tumors (who will be undergoing previously planned tumor and regional nodes dissection), we will evaluate PBA-0405's ability to trigger a variety of immune-mediated effector functions that kill tumor cells, within the local tumor microenvironment. The CIVO device penetrates solid tumors and 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. At the time of the planned surgical intervention (one to two 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. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06273852
Study type Interventional
Source Pure Biologics S.A.
Contact Presage Biosciences
Phone 800-530-5404
Email clinops@presagebio.com
Status Recruiting
Phase Early Phase 1
Start date April 29, 2024
Completion date March 2025

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