Metastatic Pancreatic CancerPhase 2NCT02340117
Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer
A Phase 2 study testing SGT-53, nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by SynerGene Therapeutics, Inc. at 1 site in United States.
Trial summary
This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- SGT-53, nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 histologic or cytologic diagnosis of stage IV metastatic pancreatic adenocarcinoma.
- One or more tumors measurable on CT scan.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Life expectancy of at least 3 months.
- Age ≥ 18 years.
- Signed, written IRB-approved informed consent.
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- A negative pregnancy test (if female and of child-bearing potential).
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT), ALT (SGPT) ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 X ULN
- Acceptable hematologic status:
- Absolute neutrophil count ≥ 1500 cells/mm³
- Platelet count ≥ 100,000 (plt/mm³)
- Hemoglobin ≥ 10 g/dL
- Acceptable blood sugar control
- Fasting glucose value ≤ 160 mg/dL
- Urinalysis: No clinically significant abnormalities.
- PT and PTT ≤ 1.5 X ULN
- For men and women of child-producing potential, willingness to use of effective contraceptive methods during the study.
- NOT have received any prior cytotoxic chemotherapy or investigational therapy. However, this study may be used as 2nd line treatment of patients who progressed on or were intolerant of 1st line FOLFIRINOX for the primary or metastatic disease. Prior treatment with gemcitabine administered as radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- They also must NOT have received chemotherapy, radiotherapy, surgery or investigational therapy for the treatment of metastatic disease.
- Organ function characterized by ≤ Grade 1.
Who cannot join
- Patient has received any prior cytotoxic chemotherapy for pancreatic cancer with the exception of patients who progressed on or were intolerant of 1st line FOLFIRINOX in primary or metastatic disease. Prior treatment with gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients who previously had and were treated with standard therapy for non-pancreatic cancer will be evaluated for entry into the trial on a case-by-case basis.
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, unstable angina (chest pain greater than three times weekly while on therapy), evidence of ischemia on ECG, or abnormal stress echocardiogram with evidence of ischemia, or LVEF < 50%.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Treated with antibiotics for infection within one week prior to study entry.
- Fever (> 38.1°C)
- Have hematological malignancy
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- Have diastolic blood pressure of > 90 mm Hg resting at baseline despite medication.
- Pregnant or nursing women.
- Treatment with surgery, or investigational therapy within 28 days prior to study entry or radiation therapy within 6 months prior to study entry.
- Have received chemotherapy, radiotherapy, surgery or investigational therapy for the treatment of metastatic disease.
- Unwillingness or inability to comply with procedures required in this protocol.
- Known infection with HIV, Hepatitis B, or Hepatitis C.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Patients who are currently receiving any other investigational agent.
- Patients who are currently taking Coumadin or Coumadin derivatives other than to maintain patency of venous access lines.
- Receiving systemic steroids or other chronic immunosuppressive medications within 30 days prior to study entry
- Receiving hematopoietic growth factors on a regular basis
- Had within six months prior to enrollment any of the following:
- Cerebrovascular accident
- Uncontrolled congestive heart failure
- Have significant baseline neuropathies
- Requires renal dialysis
- Had prior exposure to gene vector delivery products
- Had previously experienced a severe hypersensitivity reaction to gemcitabine or nab-paclitaxel
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Crowley Cancer Research Center
Dallas, Texas, 75201
About this study
Official title: Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer
This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month (PFS5.5mos)) of this combination therapy.
Read the detailed description
The p53 is a vital human tumor suppressor gene. Loss of p53 suppressor function is present in the majority of human cancers. The p53 protein has a diverse range of functions including regulation of cell cycle checkpoints, cell death (apoptosis), senescence, DNA repair, maintenance of genomic integrity, and control of angiogenesis. Abnormalities of the p53 gene may impact the efficacy of standard anticancer treatments such as radiation and chemotherapy. P53 mutation and pathway dysfunction are associated with poor clinical outcomes and the presence of the p53 mutation correlates with resistance to chemotherapy and radiation. The development of somatic gene therapy has created the potential to restore wild type function of p53. SGT-53 is a complex of cationic liposome encapsulating a normal human wild type p53 DNA sequence in a plasmid backbone. This complex has been shown to efficiently and specifically deliver the p53 cDNA to the tumor cells. Introduction of the p53 cDNA sequence is expected to restore wtp53 function in the apoptotic pathway. P53 restoration has been shown most effective in enhancing cytotoxicity in combination with an agent which results in DNA damage or initiates apoptosis. This is a Phase II clinical trial of SGT-53 plus the recently approved chemotherapeutic combination of gemcitabine/Abraxane® (nab-paclitaxel) in patients with confirmed metastatic pancreatic cancer. In addition to determining Progression Free Survival at 5.5 months (PFS5.5mos), this trial will evaluate the response rate, overall survival and time to progression as well as the tolerability and safety of SGT-53 in combination with gemcitabine/nab-paclitaxel.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- SGT-53, nab-paclitaxel, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGT-53Genetic
The dose of SGT-53 will be 3.6 mg DNA/infusion. If necessary, the dose of SGT-53 can be de-escalated to 2.4 mg, 1.2 mg or 0.6 mg DNA per infusion in the event that increased toxicity probably or definitely related to SGT-53 is observed with the combination.
nab-paclitaxelDrug
Also called Abraxane ABI-007, Albumin-bound paclitaxel
The dose of nab-paclitaxel will be 125 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7. If increased toxicities related to administration of nab-paclitaxel is observed, the dose of nab-paclitaxel can be reduced to 100 or 75 mg/m² when appropriate.
GemcitabineDrug
Also called Gemzar
The dose of gemcitabine will be 1000 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7, after the administration of nab-paclitaxel. If increased toxicities related to administration of gemcitabine is observed, the dose of gemcitabine can be reduced to 800 or 600 mg/m² when appropriate.
| Study group | Role | What they receive |
|---|---|---|
| SGT-53 with gemcitabine/nab-paclitaxel | Experimental | A course of therapy will include 7 weeks of treatment. SGT-53, at 3.6 mg DNA/infusion, will be administered bi-weekly on days 1 and 5 in weeks 1-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7. Patients who are responding to treatment may receive two additional courses (7 weeks) of SGT-53/gemcitabine/nab-paclitaxel therapy at investigator discretion. If still responding to treatment, they may continue on SGT-53/gemcitabine/nab-paclitaxel at investigator discretion with the approval of the sponsor. Receives: Genetic: SGT-53; Drug: nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) at 5.5 months
PFS5.5mos will be assessed by objective radiographic assessment
Measured: 5.5 months
Objective response rate (ORR)
ORR will be assessed by objective radiographic assessment using RECIST 1.1 criteria
Measured: Up to 5 years
Secondary outcomes (6)
Progression free survival (PFS)
Progression free survival (PFS) will be defined as the time from registration until confirmed tumor progression or death, whichever occurs first.
Measured: Up to 5 years
Overall survival (OS)
Survival will be defined as the time from the date of registration to the date of death (any cause).
Measured: Up to 5 years
Time to disease progression (TTP)
Time to disease progression is defined as the time from registration until confirmed tumor progression, but not including deaths.
Measured: Up to 5 years
Disease control rate (DCR)
Disease control rate (SD for ≥16 weeks plus CR and PR) will be analyzed using Kaplan-Meier methods.
Measured: 16 weeks
Duration of disease control
Disease control duration is measured from the time of registration until documented confirmed tumor progression.
Measured: Up to 5 years
Adverse events
Safety will be evaluated by the incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), physical examination, laboratory abnormalities during study drug dosing and percentage of patients experiencing dose modifications, interruptions, and/or discontinuation.
Measured: Study drug initiation through 30 days after the last dose of study drug or end of treatment, whichever is later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynerGene Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minal Barve, MD, Principal investigator, Mary Crowley Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340117
- Sponsor's protocol ID
- SGT53-02-1
- Status last verified
- May 2025
- First submitted
- 18 Dec 2014
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02340117
- Acronym / sponsor ID
- SGT53-02-1
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- SynerGene Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jan 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.
This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month (PFS5.5mos)) of this combination therapy.
Detailed description
The p53 is a vital human tumor suppressor gene. Loss of p53 suppressor function is present in the majority of human cancers. The p53 protein has a diverse range of functions including regulation of cell cycle checkpoints, cell death (apoptosis), senescence, DNA repair, maintenance of genomic integrity, and control of angiogenesis. Abnormalities of the p53 gene may impact the efficacy of standard anticancer treatments such as radiation and chemotherapy. P53 mutation and pathway dysfunction are associated with poor clinical outcomes and the presence of the p53 mutation correlates with resistance to chemotherapy and radiation. The development of somatic gene therapy has created the potential to restore wild type function of p53. SGT-53 is a complex of cationic liposome encapsulating a normal human wild type p53 DNA sequence in a plasmid backbone. This complex has been shown to efficiently and specifically deliver the p53 cDNA to the tumor cells. Introduction of the p53 cDNA sequence is expected to restore wtp53 function in the apoptotic pathway. P53 restoration has been shown most effective in enhancing cytotoxicity in combination with an agent which results in DNA damage or initiates apoptosis. This is a Phase II clinical trial of SGT-53 plus the recently approved chemotherapeutic combination of gemcitabine/Abraxane® (nab-paclitaxel) in patients with confirmed metastatic pancreatic cancer. In addition to determining Progression Free Survival at 5.5 months (PFS5.5mos), this trial will evaluate the response rate, overall survival and time to progression as well as the tolerability and safety of SGT-53 in combination with gemcitabine/nab-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGT-53 with gemcitabine/nab-paclitaxel | Experimental | Genetic: SGT-53, Drug: nab-paclitaxel, Drug: GemcitabineA course of therapy will include 7 weeks of treatment. SGT-53, at 3.6 mg DNA/infusion, will be administered bi-weekly on days 1 and 5 in weeks 1-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7. Patients who are responding to treatment may receive two additional courses (7 weeks) of SGT-53/gemcitabine/nab-paclitaxel therapy at investigator discretion. If still responding to treatment, they may continue on SGT-53/gemcitabine/nab-paclitaxel at investigator discretion with the approval of the sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients with histologic or cytologic diagnosis of stage IV metastatic pancreatic adenocarcinoma.
- One or more tumors measurable on CT scan.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Life expectancy of at least 3 months.
- Age ≥ 18 years.
Key exclusion criteria (24 listed)
- Patient has received any prior cytotoxic chemotherapy for pancreatic cancer with the exception of patients who progressed on or were intolerant of 1st line FOLFIRINOX in primary or metastatic disease. Prior treatment with gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients who previously had and were treated with standard therapy for non-pancreatic cancer will be evaluated for entry into the trial on a case-by-case basis.
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, unstable angina (chest pain greater than three times weekly while on therapy), evidence of ischemia on ECG, or abnormal stress echocardiogram with evidence of ischemia, or LVEF < 50%.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Treated with antibiotics for infection within one week prior to study entry.
- Fever (> 38.1°C)
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 |
|---|---|---|
| SGT-53The dose of SGT-53 will be 3.6 mg DNA/infusion. If necessary, the dose of SGT-53 can be de-escalated to 2.4 mg, 1.2 mg or 0.6 mg DNA per infusion in the event that increased toxicity probably or definitely related to SGT-53 is observed with the combination. | Genetic | SGT-53 with gemcitabine/nab-paclitaxel |
| nab-paclitaxelAlso: Abraxane ABI-007, Albumin-bound paclitaxelThe dose of nab-paclitaxel will be 125 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7. If increased toxicities related to administration of nab-paclitaxel is observed, the dose of nab-paclitaxel can be reduced to 100 or 75 mg/m² when appropriate. | Drug | SGT-53 with gemcitabine/nab-paclitaxel |
| GemcitabineAlso: GemzarThe dose of gemcitabine will be 1000 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7, after the administration of nab-paclitaxel. If increased toxicities related to administration of gemcitabine is observed, the dose of gemcitabine can be reduced to 800 or 600 mg/m² when appropriate. | Drug | SGT-53 with gemcitabine/nab-paclitaxel |
Primary outcome
Progression free survival (PFS) at 5.5 months
Time frame: 5.5 months
PFS5.5mos will be assessed by objective radiographic assessment
Objective response rate (ORR)
Time frame: Up to 5 years
ORR will be assessed by objective radiographic assessment using RECIST 1.1 criteria
6 secondary outcomes
Progression free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Time to disease progression (TTP)
Time frame: Up to 5 years
Disease control rate (DCR)
Time frame: 16 weeks
Duration of disease control
Time frame: Up to 5 years
Adverse events
Time frame: Study drug initiation through 30 days after the last dose of study drug or end of treatment, whichever is later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Minal Barve, MD principal investigator
Mary Crowley Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGT-53, nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by SynerGene Therapeutics, Inc. 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 23 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 30 May 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
Progression free survival (PFS) at 5.5 months (time frame: 5.5 months). 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 30 May 2025.