ER-Negative PR-Negative HER2-Negative Breast CancerPhase 1TNBCNCT02531425
Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC
A Phase 1 study testing IT-pIL12-EP in people with ER-Negative PR-Negative HER2-Negative Breast Cancer, run by OncoSec Medical Incorporated at 1 site in United States.
Trial summary
Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ER-Negative PR-Negative HER2-Negative Breast Cancer
- What is being tested?
- IT-pIL12-EP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment-refractory triple negative breast cancer (TNBC). *Treatment refractory disease is defined as the persistence of tumor lesions following at least one intervention that may include chemotherapy, radiation and/or surgery, or any combination thereof. *Patients must have both ER and PR staining < 5% and be HER2-negative. Patients with ER or PR staining of 5-10%, but who have historically been treated as TNBC may also be enrolled. *Patients must not have disease that, in the opinion of the investigator, is considered amenable to potentially curative treatment.
- Age ≥ 18 years.
- ECOG Performance Status of 0-1.
- Life expectancy ≥ 6 months.
- Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field. Radiation treatment must be completed ≥ 4 weeks prior to Cycle 1 Day 1.
- Adequate hepatic function with total bilirubin and ALT < 1.5X the upper limit of normal (ULN), except in patients with Gilbert's Syndrome must have a total bilirubin < 3X ULN and ALT < 3X ULN. In cases of known liver metastases, ALT ≤ 5X ULN is acceptable (total bilirubin must be < 1.5X ULN).
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- Adequate renal function, estimated or calculated creatinine clearance of > 50 mL/min (calculated using the formula of Cockcroft and Gault) -or- serum creatinine ≤ 2.0 mg/dL.
- Adequate hematological function, defined as ANC ≥ 1,500/mm3, Hb ≥ 9.0 g/dL, and platelet count ≥ 100,000/mm3.
- Lesions that are accessible for injection and electroporation, defined as cutaneous or subcutaneous disease.
- At least 2 anatomically distinct lesions accessible for biopsy.
- Must consent to study-specific biopsies at two separate timepoints: pre-treatment (Screening) and post-treatment (Day 28 or EOS).
- Tumor lesions in the CNS are permitted but lesions must have been stable for at least 3 months prior to Cycle 1 Day 1 (C1D1). Stable CNS lesions are defined as not requiring steroid prophylaxis or other medications to prevent seizures or other complications associated with CNS lesions and no evidence of worsening of CNS disease.
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to C1D1 and agree to use dual methods of contraception during the study and for a minimum of 30 days following the last treatment. Post menopausal females (>45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements.
- Male patients must use an effective barrier method of contraception during the study and for a minimum of 30 days following the last treatment if sexually active with a female of childbearing potential.
- Resolution of all treatment-related toxicities, except alopecia, anemia and neuropathy, from any previous cancer therapy to ≤ Grade 1 prior to the first dose of study treatment.
- Ability to provide written informed consent.
Who cannot join
- Any other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.
- Patients with electronic pacemakers or defibrillators.
- Chemotherapy or hormonal therapy for anti-cancer treatment within 28 days prior to Cycle 1 Day 1.
- Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
- Treatment with unapproved investigational therapeutic agent within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
- Patients receiving systemic steroid therapy for a chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's Disease, etc.). Topical steroids are also excluded. Nasal and inhaled steroids are permitted.
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- Unstable/inadequate cardiac function:
- symptomatic ischemia
- uncontrolled or clinically significant conduction abnormalities; first degree AV block or asymptomatic LAFB/RBBB are eligible
- myocardial infarction in the previous six months
- congestive heart failure (New York Heart Association class III to IV)
- Major surgery within 28 days prior to C1D1.
- Infection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to C1D1.
- Patients who are known to have HIV infection/seropositivity.
- Active Hepatitis A, B, or C infection or known to be positive for HCV RNA or HBV surface antigen. Patients who have been vaccinated against Hepatitis B and who are positive for ONLY the Hepatitis B surface antibody are permitted to participate in the study.
- Serious psychiatric or medical conditions that could interfere with treatment or protocol-related procedures.
- Patients who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Stanford, California, 94305-5826
About this study
Official title: Evaluation of Pharmacodynamic Effects of Intratumoral Delivery of Plasmid IL-12 Electroporation in Patients With Triple Negative Breast Cancer
Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single 28-day cycle.
Read the detailed description
This pilot study will evaluate the pharmacodynamic effects of intratumoral injection of pIL-12 followed immediately by electroporation (IT-pIL12-EP). A minimum of ten patients with biopsy-accessible triple negative breast cancer (TNBC) will be treated in this study. Additional patients, up to a maximum of 25 patients, may be enrolled based upon pharmacodynamic observations and at the discretion of the Principal Investigator, in consultation with the Sponsor. All patients will receive a single 28-day treatment cycle. One lesion will remain untreated (the control lesion). Treatment will be administered on Days 1,5, and 8 of the single 28-day cycle. Treatments will consist of direct injection of pIL-12 into tumor lesions, followed immediately by electroporation of the lesions. At the end of the treatment cycle, patients will return to clinic for a final safety evaluation and tumor biopsy. This end of study (EOS) visit will occur prior to initiating any new anti-cancer therapy/regimen.
All patients will undergo tumor biopsies at two separate timepoints for molecular and histological analyses associated with the primary endpoint. At least one lesion will be biopsied at Screening (pre-treatment sample). Biopsies of the untreated control lesion and at least one treated lesion will be obtained at the EOS visit (post-treatment samples). Additional tumor biopsy samples may be requested if there is either tumor regression or progression prior to EOS.
Duration of participation will be approximately 4 weeks for each patient. A patient is considered to have completed the study if all three IT-pIL12-EP treatments (Days 1, 5, \& 8) and all required pre- and post-treatment tumor biopsies have been obtained and EOS safety follow-up evaluations have been performed.
- Being tested
- IT-pIL12-EP
- Keywords
- TNBC, Triple Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IT-pIL12-EPBiological
Also called intratumoral plasmid-IL-12 + Electroporation
Intratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions
| Study group | Role | What they receive |
|---|---|---|
| IT-pIL12-EP | Experimental | intratumoral injection of plasmid-IL12 following immediately by electroporation Receives: Biological: IT-pIL12-EP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the proportion of intratumoral lymphocyte subsets
Paired tumor biopsy samples will be quantitatively analyzed for the number and distribution of tumor infiltrating lymphocytes (TILs).
Measured: 28 days
NanoString-based gene expression
Comparison of NanoString-based gene expression profiles will be completed from paired tumor samples obtained pre- and post-treatment
Measured: 28 days
Secondary outcomes (3)
Number of Participants with Treatment-Related Adverse Events as assessed by the CTCAE v4.0
Patients will be evaluated throughout study participation with physical exams and standard clinical laboratory tests (e.g., hematology, serum chemistry) for the occurrence of adverse events. The incidence and severity of treatment-related adverse events will reported using descriptive statistics.
Measured: 28 days
Anti-tumor activity
Describe evidence of anti-tumor activity
Measured: 28 days
Detection of plasmid IL-12 in untreated lesions
Assessment of plasmid IL-12 expression for biodistribution evaluation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER-Negative PR-Negative HER2-Negative 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoSec Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharron Gargosky, PhD, Study director, OncoSec Medical Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531425
- Sponsor's protocol ID
- OMS-I140
- Acronym
- TNBC
- Status last verified
- May 2023
- First submitted
- 18 Aug 2015
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacodynamic Effects of Intratumoral Delivery of Plasmid IL-12 Electroporation in Patients With Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02531425
- Acronym / sponsor ID
- TNBC / OMS-I140
- Keywords
- TNBC, Triple Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OncoSec Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single 28-day cycle.
Detailed description
This pilot study will evaluate the pharmacodynamic effects of intratumoral injection of pIL-12 followed immediately by electroporation (IT-pIL12-EP). A minimum of ten patients with biopsy-accessible triple negative breast cancer (TNBC) will be treated in this study. Additional patients, up to a maximum of 25 patients, may be enrolled based upon pharmacodynamic observations and at the discretion of the Principal Investigator, in consultation with the Sponsor. All patients will receive a single 28-day treatment cycle. One lesion will remain untreated (the control lesion). Treatment will be administered on Days 1,5, and 8 of the single 28-day cycle. Treatments will consist of direct injection of pIL-12 into tumor lesions, followed immediately by electroporation of the lesions. At the end of the treatment cycle, patients will return to clinic for a final safety evaluation and tumor biopsy. This end of study (EOS) visit will occur prior to initiating any new anti-cancer therapy/regimen.
All patients will undergo tumor biopsies at two separate timepoints for molecular and histological analyses associated with the primary endpoint. At least one lesion will be biopsied at Screening (pre-treatment sample). Biopsies of the untreated control lesion and at least one treated lesion will be obtained at the EOS visit (post-treatment samples). Additional tumor biopsy samples may be requested if there is either tumor regression or progression prior to EOS.
Duration of participation will be approximately 4 weeks for each patient. A patient is considered to have completed the study if all three IT-pIL12-EP treatments (Days 1, 5, \& 8) and all required pre- and post-treatment tumor biopsies have been obtained and EOS safety follow-up evaluations have been performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IT-pIL12-EP | Experimental | Biological: IT-pIL12-EPintratumoral injection of plasmid-IL12 following immediately by electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment-refractory triple negative breast cancer (TNBC). *Treatment refractory disease is defined as the persistence of tumor lesions following at least one intervention that may include chemotherapy, radiation and/or surgery, or any combination thereof. *Patients must have both ER and PR staining < 5% and be HER2-negative. Patients with ER or PR staining of 5-10%, but who have historically been treated as TNBC may also be enrolled. *Patients must not have disease that, in the opinion of the investigator, is considered amenable to potentially curative treatment.
- Age ≥ 18 years.
- ECOG Performance Status of 0-1.
- Life expectancy ≥ 6 months.
- Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be treated are within the radiation field. Radiation treatment must be completed ≥ 4 weeks prior to Cycle 1 Day 1.
Key exclusion criteria (17 listed)
- Any other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.
- Patients with electronic pacemakers or defibrillators.
- Chemotherapy or hormonal therapy for anti-cancer treatment within 28 days prior to Cycle 1 Day 1.
- Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
- Treatment with unapproved investigational therapeutic agent within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
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 |
|---|---|---|
| IT-pIL12-EPAlso: intratumoral plasmid-IL-12 + ElectroporationIntratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions | Biological | IT-pIL12-EP |
Primary outcome
Changes in the proportion of intratumoral lymphocyte subsets
Time frame: 28 days
Paired tumor biopsy samples will be quantitatively analyzed for the number and distribution of tumor infiltrating lymphocytes (TILs).
NanoString-based gene expression
Time frame: 28 days
Comparison of NanoString-based gene expression profiles will be completed from paired tumor samples obtained pre- and post-treatment
3 secondary outcomes
Number of Participants with Treatment-Related Adverse Events as assessed by the CTCAE v4.0
Time frame: 28 days
Anti-tumor activity
Time frame: 28 days
Detection of plasmid IL-12 in untreated lesions
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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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.
Sharron Gargosky, PhD study director
OncoSec Medical Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IT-pIL12-EP in people with ER-Negative PR-Negative HER2-Negative Breast Cancer, run by OncoSec Medical Incorporated 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 16 inclusion and 17 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: finished, as of the sponsor's last update on 15 May 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the proportion of intratumoral lymphocyte subsets (time frame: 28 days). The study lists 2 primary outcomes in all. 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 15 May 2023.