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.

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Updated on 22 March 2022

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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 Identifier	NCT02340117
Sponsor	SynerGene Therapeutics, Inc.
Last Modified on	22 March 2022

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