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

NCT02423902 | Terminated Phase 1 Results

• 1 other identifier: ATI001-203
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation

  Composite measure of safety and tolerability based on lab parameters, vitals, physical examination data and deaths, SAEs, and AEs resulting in patient discontinuation. Toxicity stopping rules when applicable will be determined based on a clinical assessment made by the SRC. The Sponsor conducted an additional ad hoc analysis of study-drug-related-TEAEs with an onset during the dosing period of all cycles to assess the number subjects with events of cytokine release syndrome (CRS), to include TEAEs that were symptoms of CRS, including when the PI did not report the preferred term of CRS. Results of this ad hoc assessment are reported here.

  1 year

Secondary Outcomes (9)

• Progression Rate at 12 Weeks After the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy

  12 weeks

• Overall Response Rate (ORR), Defined as the Rate of Complete Response (CR) Plus the Rate of Partial Response (PR) at 12 Weeks Following the Start of Ad-RTS-hIL-12 Immunotherapy

  12 weeks

• Disease Control Rate (DCR), Defined as the Proportion of Subjects Who Have a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at 12 Weeks Following the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy

  12 weeks

• Number of Subjects Whose Baseline Tumor Status (Stable Disease or Partial Response) Improves to Partial Response or Better at 12 Weeks Following the Start of Ad-RTS-hIL-12 Immunotherapy

  12 weeks

• Comparison of Radiographic Tumor Responses by irRC With RECIST

  12 weeks

Study Arms (1)

Ad-RTS-hIL-12 + Veledimex

EXPERIMENTAL

Intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex

Biological: Ad-RTS-hIL-12; Drug: Veledimex

Interventions

Ad-RTS-hIL-12 BIOLOGICAL

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

Also known as: INXN-2001

Ad-RTS-hIL-12 + Veledimex

Veledimex DRUG

7 oral doses of veledimex

Also known as: INXN-1001 (activator ligand)

Ad-RTS-hIL-12 + Veledimex

Eligibility Criteria

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

You may qualify if:

• Female, age ≥ 18 years
• Histologically-confirmed, locally advanced or metastatic adenocarcinoma of the breast
• Achievement of SD or PR after a minimum of 12 weeks of pre-study first- or second-line standard chemotherapy
• Presence of at least 2 measurable lesions
• Standard treatment interrupted, except if anti-HER2 therapy
• All treatment-related or radiation-related toxicities resolved to Grade 1 or lower
• Submission of copies of tumor measurements and scans
• Life expectancy \> 12 weeks
• ECOG performance status of 0 to 1
• Adequate bone marrow function
• Adequate liver function
• Adequate renal function
• Female subjects and their male partners must agree must agree to use a highly reliable method of birth control
• Able to swallow oral medication
• Willing to comply with study procedures

You may not qualify if:

• Metastatic breast cancer patients currently on hormonal therapy as first- or second-line are not permitted
• Prior radiation therapy encompassing \> 25% of bone marrow
• Any congenital or acquired condition leading to compromised ability to generate an immune response
• Immunosuppressive therapy
• Use of systemic immunosuppressive drugs
• Requirement for continual immune suppression
• Major surgery within 4 weeks of study treatment
• An active, second potentially life-threatening cancer
• Presence of brain or subdural metastases
• Any signs and/or symptoms of brain metastases must be stable for ≥ 4 weeks
• Radiographic stability should be determined by comparing contrast-enhanced CT or MRI scans at screening to scans obtained by the same method at least 4 weeks earlier
• Presence or documented history of any of the following autoimmune conditions:
• Inflammatory bowel disease
• Rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis
• Motor neuropathy considered of autoimmune origin

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

veledimex

Condition Hierarchy (Ancestors)

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

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 22, 2015
• Study Start: July 18, 2015
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Locations

US (1)