NCT02423902

A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer

A Single-arm, Open-label Study of Ad-RTS-hIL-12 + Veledimex Following First-, Second-, or Third-Line Standard Treatment in Subjects With Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer and pre-study SD or PR after completion of a minimum 12 week course of standard first- or second-line chemotherapy. The patient population will include patients with locally advanced or metastatic breast cancer of all subtypes.

Detailed description

Subjects who have PD or a CR after the standard chemotherapy are not eligible for the study. Following entry into the trial, patients will go on a treatment holiday from chemotherapy and enter an immunotherapy phase of treatment. Continuation of HER2-targeted antibody therapy is permitted during this immunotherapy phase for women with HER2+ disease. Scans will be conducted at 6 and 12 weeks after the start of Ad-RTS-hIL-12 immunotherapy to determine tumor response. Radiographic PD at week 6 must be confirmed at least 4 weeks later, either at week 12 or earlier if clinically necessitated.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ad-RTS-hIL-12	Approximately 1.0x10\^12 viral particles (vp) per injection
DRUG	Veledimex	7 oral doses of veledimex

Timeline

• Start date: 2015-07-18
• Primary completion: 2016-07-19
• Completion: 2016-07-19
• First posted: 2015-04-22
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

1 site across 1 country: United States