NCT01703754

Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

A Phase II Randomized, Open Label Study of Ad-RTS-hIL-12 Monotherapy or Combination With Palifosfamide in Subjects With Recurrent/Metastatic Breast Cancer and Accessible Lesions

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.

Detailed description

Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide. Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy. Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C. Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin. Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.

Conditions

• Breast Cancer Nos Metastatic Recurrent

Interventions

Type	Name	Description
GENETIC	Ad-RTS-hIL-12 and Veledimex	Oral activator ligand with adenoviral vector injection of cancer lesions
DRUG	Palifosfamide	Small molecule chemotherapy, IV administration

Timeline

• Start date: 2013-04-04
• Primary completion: 2014-08-07
• Completion: 2014-08-07
• First posted: 2012-10-10
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

8 sites across 1 country: United States