A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors
Presage Biosciences
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.
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 utilizi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
\*This list is representative of study inclusion/exclusion criteria. Each substudy may include variations on these criteria. Inclusion Criteria: 1. Ability and willingness to comply with the study's visit and assessment schedule. 2. Male or female ≥ 18 years of age at Visit 1 (Screening). 3. Pathologic diagnosis of \[solid tumors\] indicated in the relevant substudy(ies). 4. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consen…
Interventions
- BiologicalRilvegostomig
Intratumoral microdose injection by the CIVO device.
- BiologicalVolrustomig
Intratumoral microdose injection by the CIVO device.
- BiologicalSabestomig
Intratumoral microdose injection by the CIVO device.
- BiologicalPembrolizumab
Intratumoral microdose injection by the CIVO device.
Locations (12)
- UC DavisSacramento, California
- Emory Winship Cancer InstituteAtlanta, Georgia
- LSU Health Sciences Center - ShreveportShreveport, Louisiana
- Montefiore Medical CenterThe Bronx, New York
- University of North CarolinaChapel Hill, North Carolina
- Wake Forest University Health SciencesWinston-Salem, North Carolina