Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer
Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer
Doctors at the Mary Crowley Cancer Research Center seek participants with metastatic pancreatic cancer to undergo a genetic therapy to improve expression of a tumor suppression gene that halts tumor replication, or growth. The investigatory treatment delivers a specially engineered loop of DNA. The DNA works to produce molecules to regulate normal cell death that the tumor has stopped making, This drug, called SGT-53 nanocomplex, is given in combination with gemcitabine/Abraxane® chemotherapy (the standard of care for such tumors).
The drug will be infused 2x weekly for 7 weeks, with gemcitabine/Abraxane® will be administered by mouth 1x weekly. The frequency of dosage may increase over the 7 weeks, and if tolerated well, a second cycle of 7 weeks is optional. Chemotherapy may also continue if well-tolerated and doctors agree. The goal is for patients to experience progression-free survival of their cancer for over 5 months, with follow-up for 2 years.
- Be 18 years of age and older
- Have histologic or cytologic diagnosis of stage IV metastatic pancreatic adenocarcinoma
- Not be pregnant or breast-feeding
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- In week 1 SGT-53 will be administered on day 1 and day 5,
- Gemcitabine chemotherapy will be administered on day 3 of each week except week 4.
- If the combination is well-tolerated, starting at week 2, infusion of SGT-53 will be administered bi-weekly on days 1 and 5 in weeks 2-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7.
- Patients who are responding to treatment may receive one additional course (7 weeks) of SGT-53/gemcitabine therapy at investigator discretion. If still responding to treatment, they may continue on gemcitabine/nab-paclitaxel alone at investigator discretion.
- Follow up will continue for 2 years.
LOCATIONS AND CONTACTS:
The study site is at Mary Crowley Cancer Research Center in Dallas, TX, Map.
Referral Office | 972-566-3000 | [email protected]
Alyssa Roth | 972-566-3061 | [email protected]
SynerGene Therapeutics, Inc..
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