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NCT04367675 · ClinicalTrials.gov registry record · Phase 1

INO 5401 Vaccination in BRCA1/2 Mutation Carriers

A Phase 1 study of BRCA1/2 Mutation, sponsored by Abramson Cancer Center at Penn Medicine.

Active
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT04367675: Active Phase 1 study of BRCA1/2 Mutation, sponsored by Abramson Cancer Center at Penn Medicine.

NCT04367675 is a Phase 1 study of BRCA1/2 Mutation that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04367675, a Phase 1 study of BRCA1/2 Mutation, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Primary Outcome

Dose-limiting toxicities will be classified by system organ class (SOC), preferred term (PT), severity, and relationship to Study Treatment.

Conditions Studied

Interventions

  • DRUG INO-5401
  • DRUG INO-9012
  • DEVICE Cellectra 2000

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2021-04-20
Est. Completion 2027-03
Phase Phase 1

What the registry record for NCT04367675 still lists

NCT04367675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).

The record links to 1 condition, with BRCA1/2 Mutation appearing as the primary indexed condition, and to 3 interventions - of which INO-5401 is the first listed.

NCT04367675 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04367675 about?

NCT04367675 is a clinical study titled "INO 5401 Vaccination in BRCA1/2 Mutation Carriers". The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vac...

What is the current status of trial NCT04367675?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-04-20. Estimated completion is 2027-03.

What conditions does trial NCT04367675 study?

This clinical trial studies the following conditions: BRCA1/2 Mutation.

What interventions are being tested in trial NCT04367675?

The interventions under investigation include: INO-5401 (DRUG), INO-9012 (DRUG), Cellectra 2000 (DEVICE).

Who is sponsoring clinical trial NCT04367675?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04367675 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04367675's enrollment target sits among peer trials

44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT04367675, the US trial registry maintained by the National Library of Medicine. NCT04367675 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.