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NCT04541108

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

Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
Presage Biosciences
~15 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:RilvegostomigVolrustomigSabestomigPembrolizumabAZD9592AZD9592 + Rilvegostomig

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantification of Selected Pharmacodynamic Biomarkers as Specified in Substudies by IHC, ISH, and/or Spatial Biology Platforms
Measured over 4 hours-7 days after microdose injection

Conditions

Solid Tumor

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Where it's being run

9 sites across 8 states
South Carolina2
Louisiana1
New York1
North Carolina1
Ohio1
Oregon1
Pennsylvania1
Washington1

Study leadership

  • Study Director · STUDY_DIRECTOR · Presage Biosciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Are postmenopausal for at least one year before the screening visit, OR
Are surgically sterile, OR
Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) and during study participation OR agree to completely abstain from heterosexual intercourse.
Agree to refrain from donating ova during study participation.
Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse.
Agree to refrain from donating sperm during study participation.

Exclusion

Both lactating and breastfeeding, OR
Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator. 3. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.

What this trial measures

  • Quantification of Selected Pharmacodynamic Biomarkers as Specified in Substudies by IHC, ISH, and/or Spatial Biology Platforms4 hours-7 days after microdose injection

    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, ISH, or spatial biology platforms. An aggregate analysis of this quantification may be done across patient samples in each substudy to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to biomarkers for cell death (e.g. cleaved caspase 3), T-cells (e.g. CD3, CD8/Granzyme B, CD4), natural killer (NK)/myeloid cells (e.g. CD56/Granzyme B, CD86, CD68, CD163), and proinflammatory cytokines (e.g., interferon gamma, tumor necrosis factor alpha, interferon gamma-induced protein 10).