CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
INXN-2001 +1 morebiological
Likely dose
INXN-1001 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01397708
NCT01397708Phase 2Completed
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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

Alaunos Therapeutics·interventional·Posted Jul 19, 2011·Updated Oct 29, 2025

In Brief

A Phase 2 clinical trial evaluating INXN-2001 and INXN-1001 for Melanoma. Completed, enrolled 26 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.0 years ago

Interventions

INXN-2001biological

* approximately 1.0 x 1012 viral particles (vp) per injection * one intratumoral injection of INXN-2001 per study cycle * maximum of 6 study cycles

INXN-1001drug

* 4 dose cohorts (5mg/day, 20mg/day, 100mg/day, and 160mg/day) * 7 oral daily doses of INXN-1001 per study cycle * maximum of 6 study cycles * 1 Expansion cohort at a single dose level at or below MTD (160mg/day)