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

Complete Title: A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients with Solid Tumors
Trial Phase: Early Phase I
Investigator: Michael Wagner, MD

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.

Keywords:
  • Solid Tumors
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Adult
Early Phase I
Michael Wagner, MD
RG1121803
NCT04541108
A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients with Solid Tumors
Solid Tumors