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

NCT01703754 | Terminated Phase 2 Results

• 1 other identifier: ATI001-201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Breast Cancer Nos Metastatic Recurrent

Keywords

Genetically Modified Organism; Metastatic Breast Cancer; Recurrent Breast Cancer; Breast Cancer; Palifosfamide; INXN1001; INXN2001; Adenoviral vector

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.

  16 months

• 16-Week Progression-Free Survival (PFS) Rate

  This is the primary efficacy endpoint, defined as the proportion of subjects who had not progressed or died prior to 16 weeks from the date of their first dose. Progression was determined by modified Response Evaluation Criteria in Solid Tumors

  16 weeks

Secondary Outcomes (11)

• Best Overall Response (BOR) by mRECIST v1.1

  24 weeks

• Estimate PFS by Modified RECIST v1.1

  16 months

• Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001

  Cycle 1 Day 1 and Cycle 1 Day 7

• Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay

  Screening and the Post-Treatment Safety Assessment visit (28 days after the last dose of study drug), with the final assessment occurring up to 7 months after the start of treatment.

• Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels

  Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment.

Study Arms (2)

Ad-RTS-hIL-12 and veledimex

EXPERIMENTAL

Experimental study drug monotherapy arm (A)

Genetic: Ad-RTS-hIL-12 and Veledimex

Ad-RTS-hIL-12 and Palifosfamide

EXPERIMENTAL

Study drug combination therapy arm (C)

Genetic: Ad-RTS-hIL-12 and Veledimex; Drug: Palifosfamide

Interventions

Ad-RTS-hIL-12 and Veledimex GENETIC

Oral activator ligand with adenoviral vector injection of cancer lesions

Also known as: Adenoviral Vector, Oral activator ligand

Ad-RTS-hIL-12 and Palifosfamide; Ad-RTS-hIL-12 and veledimex

Palifosfamide DRUG

Small molecule chemotherapy, IV administration

Also known as: Pali

Ad-RTS-hIL-12 and Palifosfamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists.
• Failed or progressed on at least 1 prior systemic chemotherapy regimen ± biologic/experimental therapy (if first-line therapy, failure or progression during the first 30 days).
• Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
• A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1.
• Eastern Cooperative Oncology Group performance status 0, 1, 2
• Male and female subjects must agree to use a highly reliable method of birth control.
• Adequate bone marrow reserve as indicated by:
• Absolute neutrophil count \> 1500/μL (without use of growth factors within 7 days)
• Absolute lymphocyte count \> 700/μL (without use of growth factors within 7 days)
• Platelet count \> 100,000/mm3 (without transfusion in prior 7 days)
• Hemoglobin \> 9.0 g/dL (without transfusion in prior 7 days)
• Estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation: eGFR ≥ 60 mL/min/1.73 m2
• Adequate liver function as evidenced by the following:
• Bilirubin ≤ 1.5 times the upper limits of normal (ULN)

You may not qualify if:

• Subjects with human epidermal growth factor receptor 2 (HER2)/neu-positive (immunohistochemistry \[IHC\]) 3+ or fluorescence in situ hybridization-amplified) breast tumors who are eligible for, but who have not received HER2-targeted therapy (eg, trastuzumab)
• Concomitant anticancer therapies
• Prior therapies discontinuation periods:
• Radiation within 3 weeks of enrollment
• Chemotherapy within 4 weeks of enrollment
• Nitrosoureas within 6 weeks of enrollment
• Biologic therapy and/or immunomodulatory therapy, checkpoint inhibitors within 6 weeks of enrollment
• No washout period is required for endocrine therapy
• Radiation therapy encompassing \>25% of bone marrow
• History of bone marrow or stem cell transplantation
• Any congenital or acquired condition leading to inability to generate an immune response
• Immunosuppressive therapy:
• Systemic immunosuppressive drugs including corticosteroids (prednisone equivalent \>10 mg/day)
• Immune suppression/requiring immunosuppressive drugs, including organ allografts
• Active autoimmune disease requiring the equivalent of \>10 mg/day of prednisone

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (8)

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 45042, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

The Jones Clinic, PC

Germantown, Tennessee, 38138, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

Evergreen Hematology & Oncology

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

veledimex; isophosphamide mustard; Palivizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jaymes Holland
• Organization: Alaunos Therapeutics

jholland@alaunos.com

6502732627

Study Officials

• Jaymes Holland

  Alaunos Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: October 10, 2012
• Study Start: April 4, 2013
• Primary Completion: August 7, 2014
• Study Completion: August 7, 2014
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Locations

US (8)