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

NCT02423902 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-08-28

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Ad-RTS-hIL-12

Approximately 1.0x10\^12 viral particles (vp) per injection

DRUG

Veledimex

7 oral doses of veledimex

Sponsors & Collaborators

  • Alaunos Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jaymes Holland · Alaunos Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-18
Primary Completion
2016-07-19
Completion
2016-07-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423902 on ClinicalTrials.gov