Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    28
  • sponsor
    SynerGene Therapeutics, Inc.
Updated on 22 March 2022
ct scan
platelet count
paclitaxel
cancer
metastasis
neutrophil count
gemcitabine
folfirinox
gemcitabine/nab-paclitaxel

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. 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.

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.

Details
Condition Metastatic Pancreatic Cancer
Treatment Gemcitabine, Nab-paclitaxel, SGT-53
Clinical Study IdentifierNCT02340117
SponsorSynerGene Therapeutics, Inc.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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