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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01397708

Public ClinicalTrials.gov record NCT01397708. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 12:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II, Open Label Study of Ad-RTS-hIL-12, an Adenovirus Vector Engineered to Express hIL-12, in Combination With an Oral Activator Ligand, in Subjects With Unresectable Stage III or IV Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01397708
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Alaunos Therapeutics
Industry
Enrollment
26 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2011 (Type not available)
Primary completion
Sep 2014 (Actual)
Completion
Sep 2014 (Actual)
Last update posted
Oct 29, 2025

2011 – 2014

United States locations

U.S. sites
9
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
The Angeles Clinic Los Angeles California 90404 —
Oncology Specialists Park Ridge Illinois 60068 —
Indiana University Health Goshen Center for Cancer Care Goshen Indiana 46526 —
James Graham Brown Cancer Center Louisville Kentucky 40202 —
Washington University St Louis Missouri 63110 —
Atlantic Melanoma Center Morristown New Jersey 07960 —
St. Lukes Easton Pennsylvania 15232 —
Mary Crowley Cancer Research Center Dallas Texas 75201 —
Fletcher Allen Health Burlington Vermont 05401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01397708, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 29, 2025 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01397708 live on ClinicalTrials.gov.

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