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NCT01397708 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma

A Phase 1 study of Melanoma, sponsored by Alaunos Therapeutics.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
9
Study locations

NCT01397708 is a Phase 1 study of Melanoma that has completed, run by Alaunos Therapeutics. The registered enrollment target is 26 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT01397708, a Phase 1 study of Melanoma, has completed, sponsored by Alaunos Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
9
Study locations

Study Summary

This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of tumor injections of INXN-2001 given in combination with different doses of INXN-1001.

Conditions Studied

Interventions

  • BIOLOGICAL INXN-2001
  • DRUG INXN-1001

Study Locations (9)

California

  • The Angeles Clinic - Los Angeles

Illinois

  • Oncology Specialists - Park Ridge

Indiana

  • Indiana University Health Goshen Center for Cancer Care - Goshen

Kentucky

  • James Graham Brown Cancer Center - Louisville

Missouri

  • Washington University - St Louis

New Jersey

  • Atlantic Melanoma Center - Morristown

Pennsylvania

  • St. Lukes - Easton

Texas

  • Mary Crowley Cancer Research Center - Dallas

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2011-08
Est. Completion 2014-09
Phase Phase 1

Sponsor

Alaunos Therapeutics

22 total trials

What the Registry Record Tells You About NCT01397708

The ClinicalTrials.gov registry entry for NCT01397708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is Alaunos Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which INXN-2001 is the first listed.

NCT01397708 reports 9 study locations spanning 9 distinct geographic areas - top geographies include California, Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT01397708 about?

NCT01397708 is a clinical study titled "Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma". This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill ...

What is the current status of trial NCT01397708?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-08. Estimated completion is 2014-09.

What conditions does trial NCT01397708 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT01397708?

The interventions under investigation include: INXN-2001 (BIOLOGICAL), INXN-1001 (DRUG).

Who is sponsoring clinical trial NCT01397708?

This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01397708 being conducted?

This trial has 9 study locations across California, Illinois, Indiana, Kentucky, Missouri. 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

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