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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The MTD will be defined as the dose level at which at most one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT

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
Vaxiion Therapeutics

2 total trials

What NCT05901285 shows while recruiting

NCT05901285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (78% lower).

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 lists 8 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05901285's enrollment target sits among peer trials

43 166th of 189 higher than 24 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05901285

Source: ClinicalTrials.gov NCT05901285, the US trial registry maintained by the National Library of Medicine. NCT05901285 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.