Metastatic Breast CancerPhase 1/2NCT02423902
A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer
A Phase 1/2 study testing Ad-RTS-hIL-12 and Veledimex in people with Metastatic Breast Cancer, run by Alaunos Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Ad-RTS-hIL-12 and Veledimex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2015to 19 Jul 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
- Presence of meningeal carcinomatosis
- Use of any medications that induce, inhibit, or are substrates of CYP450 3A4
- History or evidence of cardiac disease as indicated by any of the following:
- Congestive heart failure greater than NYHA Class II
- Unstable angina or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Congenital long QT syndrome or taking drugs known to prolong the QT interval
- Current use of any drugs with a known risk of causing torsades de pointes
- Evidence or history of thromboembolic, venous, or arterial events within the past 3 months
- Evidence or history of bleeding diathesis or coagulopathy
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x ULN, in subject who is not therapeutically anticoagulated.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Presence of active clinically serious infection
- Diagnosis of infection with HIV or chronic infection with hepatitis B or C
- Any other unstable or clinically significant concurrent medical condition
- Pregnant or breast-feeding
- Use of any investigational, non-United States Food and Drug Administration (US FDA) approved drug
- Participation in any other clinical trial
- Presence of any condition which makes the patient unsuitable
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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
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.
Read the 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
- Being tested
- Ad-RTS-hIL-12, Veledimex
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad-RTS-hIL-12Biological
Also called INXN-2001
Approximately 1.0x10^12 viral particles (vp) per injection
VeledimexDrug
Also called INXN-1001 (activator ligand)
7 oral doses of veledimex
| Study group | Role | What they receive |
|---|---|---|
| Ad-RTS-hIL-12 + Veledimex | Experimental | Intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex Receives: Biological: Ad-RTS-hIL-12; Drug: Veledimex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (9)
Progression Rate at 12 Weeks After the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
The percent of subjects that failed by 12 weeks is denoted as the progression rate, and is derived based on the sum of progression events, death events, and subjects who discontinue the trial due to an AE. Tumor assessment was performed per RECIST (progression was determined as >=20% increase in the sum of the longest diameter of target lesions and or unequivocal new lesion were present)
Measured: 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
Overall response at Week 12 is based on the totality of the responses for target and non-target lesions. For this calculation, responders are defined as those experiencing a CR or a PR. Non-responders are those either with stable or progressive disease. Those subjects who cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals.
Measured: 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
The DCR is the proportion of subjects who have a CR, PR, or stable disease at 12 weeks following the start of Ad-RTS-hIL-12 immunotherapy using RECIST v1.1. For this calculation, responders are defined as those experiencing a CR, PR, or stable disease. Non-responders are defined as those with PD. Those subjects that cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals.
Measured: 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
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
Measured: 12 weeks
Comparison of Radiographic Tumor Responses by irRC With RECIST
Best Overall Response at Week 12 after 1 cycle of Ad-RTS-hIL-12 + veledimex immunotherapy is reported for response assessment per RECIST and per irRC.
Measured: 12 weeks
Change From Baseline in Serum CA15-3 Levels
Serum levels of the cancer antigen 15-3 (CA15-3) biomarker were measured by immunoassay to explore the impact of treatment.
Measured: Screening, Week 6, and Week 12
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Serum levels of Interleukin-12 (IL-12) were measured by immunoassay to explore the impact of treatment on immune biomarkers.
Measured: Screening, Week 6, and Week 12
Change From Baseline in Serum Interferon-gamma (IFN-gamma) Levels
Serum levels of Interferon-gamma (IFN-gamma) were measured by immunoassay to explore the impact of treatment on immune biomarkers.
Measured: Screening, Week 6, and Week 12
Change From Baseline in Serum Carcinoembryonic Antigen (CEA) Levels
Serum levels of the carcinoembryonic antigen (CEA) biomarker were measured by immunoassay to explore the impact of treatment.
Measured: Screening, Week 6, and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start18 Jul 2015
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Why it stopped: The study was terminated after 9 subjects had enrolled under Protocol Amend 1 because of slower than expected accrual. Protocol Amendment 2 (16 May 2016) was submitted to the FDA and, based on the decision of the PI, was not submitted to the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaymes Holland, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423902
- Sponsor's protocol ID
- ATI001-203
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2015
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02423902
- Acronym / sponsor ID
- ATI001-203
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after 9 subjects had enrolled under Protocol Amend 1 because of slower than expected accrual. Protocol Amendment 2 (16 May 2016) was submitted to the FDA and, based on the decision of the PI, was not submitted to the IRB.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2015 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ad-RTS-hIL-12 + Veledimex | Experimental | Biological: Ad-RTS-hIL-12, Drug: VeledimexIntratumoral injection of Ad-RTS-hIL-12 in combination with veledimex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (34 listed)
- 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
- Major surgery within 4 weeks of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad-RTS-hIL-12Also: INXN-2001Approximately 1.0x10^12 viral particles (vp) per injection | Biological | Ad-RTS-hIL-12 + Veledimex |
| VeledimexAlso: INXN-1001 (activator ligand)7 oral doses of veledimex | Drug | Ad-RTS-hIL-12 + Veledimex |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Time frame: 1 year
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.
9 secondary outcomes
Progression Rate at 12 Weeks After the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Comparison of Radiographic Tumor Responses by irRC With RECIST
Time frame: 12 weeks
Change From Baseline in Serum CA15-3 Levels
Time frame: Screening, Week 6, and Week 12
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Time frame: Screening, Week 6, and Week 12
Change From Baseline in Serum Interferon-gamma (IFN-gamma) Levels
Time frame: Screening, Week 6, and Week 12
Change From Baseline in Serum Carcinoembryonic Antigen (CEA) Levels
Time frame: Screening, Week 6, and Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaymes Holland study director
Alaunos Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad-RTS-hIL-12 and Veledimex in people with Metastatic Breast Cancer, run by Alaunos Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.