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NCT05901285 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumor and Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab, sponsored by Vaxiion Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
43
Enrollment target
8
Study locations

NCT05901285 is a Phase 1 study of Advanced Solid Tumor and Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab that is actively recruiting participants, run by Vaxiion Therapeutics. The registered enrollment target is 43 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (78% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT05901285, a Phase 1 study of Advanced Solid Tumor and Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab, is actively recruiting participants, sponsored by Vaxiion Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
43 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.

Conditions Studied

Advanced Solid Tumor Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab

Interventions

  • DRUG VAX014
  • COMBINATION_PRODUCT Nivolumab or pembrolizumab

Study Locations (8)

Arizona

  • University of Arizona Cancer Center - Tucson

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

District of Columbia

  • George Washington University - Washington D.C.

Maryland

  • University of Maryland - Baltimore

Massachusetts

  • Dana Farber Cancer Institute - Boston

New Hampshire

  • Dartmouth Cancer Center - Lebanon

New Jersey

  • Atlantic Health System - Morristown

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2023-11-02
Est. Completion 2026-11
Phase Phase 1

Sponsor

Vaxiion Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05901285

The ClinicalTrials.gov registry entry for NCT05901285 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (78% lower). The listed sponsor is Vaxiion Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which VAX014 is the first listed.

NCT05901285 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Arizona, Colorado, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT05901285 about?

NCT05901285 is a clinical study titled "Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors". The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted onc...

What is the current status of trial NCT05901285?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2023-11-02. Estimated completion is 2026-11.

What conditions does trial NCT05901285 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab.

What interventions are being tested in trial NCT05901285?

The interventions under investigation include: VAX014 (DRUG), Nivolumab or pembrolizumab (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05901285?

This trial is sponsored by Vaxiion Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05901285 being conducted?

This trial has 8 study locations across Arizona, Colorado, District of Columbia, Maryland, Massachusetts. 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

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.