A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

Contact:

NCT Number:

Protocol:

AAAU1236

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II/III

The purpose of this study is to investigate how well SBP-101, the study drug, or a placebo works in combination with nap-paclixatel and gemcitabine to treat adenocarcinoma in study participants who have never received treatment for their cancer.A placebo is an inert substance that does not contain any study drug and has no therapeutic value. Placebos are used in studies to help the study team determine if any progress occurs due to the study treatment or due to another outside factor that is not being studied in this research. Participants will be randomized (randomly assigned by a computer) to the study drug group or the placebo group. The study also aims to determine how safe and well tolerated the combination of study drugs are in patients with adenocarcinoma. SBP-101 is not FDA-approved. On the contrary, nap-paclixatel and gemcitabine are approved by the FDA and are typically the standard of care treatment for your type of cancer. This study aims to see if adding SBP-101 to the standard of care treatments is a better approach than the standard of care treatments alone.

Are you Eligible? (Inclusion Criteria)

  • You must be 18 years of age or older.
  • You must not have received any other type of treatment for your cancer.
  • You must have been diagnosed with metastatic pancreatic ductal adenocarcinoma

Specialty Area(s)

Pancreatic Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Gastrointestinal Oncology
  • Director of Pancreas Translational Research

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032