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New investigational drug for untreated metastatic pancreatic cancer
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
Darren Sigal, M.D.
This research study is investigating the safety of an experimental drug called SBP-101. The main goal is to assess the safety of SBP-101 when given in combination with the standard treatment (Nab-Paclitaxel and Gemcitabine) that is typically given for this type of cancer.
Have confirmed metastatic pancreatic ductal adenocarcinoma that has been diagnosed within the past 3 months
Be 18 years or older
Have received prior treatment for metastatic pancreatic ductal adenocarcinoma/Metastatic Pancreatic Cancer;
Have known active bacterial, fungal, or viral infection requiring systemic therapy
Have known active infection with human immunodeficiency virus (HIV), hepatitis B or C
Have myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure
Be pregnant or lactating
Have major surgery within 4 weeks of start of study treatment, without complete recovery
Have participated in any other clinical investigation within 4 weeks of receiving first dose of study drug
Take Metformin. Diabetics on treatment with Metformin, or any other derivative thereof, must discontinue it while on study. (Other diabetic medications allowed)
SBP 101 is an experimental drug, that means it has not been approved by the FDA. It will be combined with standard approved chemotherapy drugs to see if it can help fight metastatic pancreatic cancer. Laboratory and animal studies suggest that SBP-101 targets and destroys the cells in the
pancreas where this tumor grows.
All treatment and physician visits during this study will take place at Scripps Clinic Torrey Pines. Up to 10 participants will be enrolled at Scripps.
Search NCT# 03412799 @ ClinicalTrials.Gov website for more details