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-0111 when administered intratumorally in microdose quantities via the CIVO device.
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Single group
PBA-0111
DrugIntratumoral microdose injection by the CIVO device.
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites in each resected patient sample by IHC and/or ISH. An aggregate analysis of this quantification may be done across patient samples to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to, drug targets (e.g., GARP, Cluster of Differentiation 16), biomarkers for cell death (e.g., cleaved caspase 3), natural killer cells (e.g., Cluster of Differentiation 56/Cluster of Differentiation 45/Granzyme B), macrophages (Cluster of Differentiation 86, Cluster of Differentiation 68, Cluster of Differentiation 163), and proinflammatory cytokines (e.g., interferon gamma, tumor necrosis factor alpha, interferon-stimulated gene 15, chemokine interferon gamma-inducible protein 10).
Number of Patients with Adverse Events
Relationship of adverse event (AE) to study drug(s) or CIVO device will be determined using an AE Relatedness Grading System
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