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NCT04541108 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Solid Tumor, sponsored by Presage Biosciences.

Recruiting
Registry status
Early Phase 1
Development phase
15
Enrollment target
12
Study locations

NCT04541108 is a Early Phase 1 study of Solid Tumor that is actively recruiting participants, run by Presage Biosciences. The registered enrollment target is 15 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (93% lower). The trial reports 12 study locations across 11 states.

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The verdict

NCT04541108, a Early Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Presage Biosciences.

RECRUITING
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target
12
Study locations

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 Studied

Solid Tumor

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Volrustomig
  • BIOLOGICAL Rilvegostomig
  • BIOLOGICAL Sabestomig

Study Locations (12)

North Carolina

  • University of North Carolina - Chapel Hill
  • Wake Forest University Health Sciences - Winston-Salem

California

  • UC Davis - Sacramento

Georgia

  • Emory Winship Cancer Institute - Atlanta

Louisiana

  • LSU Health Sciences Center - Shreveport - Shreveport

New York

  • Montefiore Medical Center - The Bronx

Ohio

  • UC Health - Cincinnati

Oregon

  • Oregon Health & Science University (OHSU) - Portland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-07-26
Est. Completion 2031-12
Phase Early Phase 1

Sponsor

Presage Biosciences

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04541108

The ClinicalTrials.gov registry entry for NCT04541108 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (93% lower). The listed sponsor is Presage Biosciences, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT04541108 reports 12 study locations spanning 11 distinct geographic areas - top geographies include North Carolina, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT04541108 about?

NCT04541108 is a clinical study titled "Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies". 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 tum...

What is the current status of trial NCT04541108?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-07-26. Estimated completion is 2031-12.

What conditions does trial NCT04541108 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT04541108?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Volrustomig (BIOLOGICAL), Rilvegostomig (BIOLOGICAL), Sabestomig (BIOLOGICAL).

Who is sponsoring clinical trial NCT04541108?

This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04541108 being conducted?

This trial has 12 study locations across California, Georgia, Louisiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.