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

NCT04541108 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Rilvegostomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Volrustomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Sabestomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Pembrolizumab

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

AZD9592

Intratumoral microdose injection by the CIVO device

COMBINATION_PRODUCT

AZD9592 + Rilvegostomig

Intratumoral microdose injection by the CIVO device

COMBINATION_PRODUCT

AZD9592 + Volrustomig

Intratumoral microdose injection by the CIVO device

COMBINATION_PRODUCT

AZD9592 + Sabestomig

Intratumoral microdose injection by the CIVO device

COMBINATION_PRODUCT

AZD9592 + Pembrolizumab

Intratumoral microdose injection by the CIVO device

Sponsors & Collaborators

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Study Director · Presage Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2031-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541108 on ClinicalTrials.gov