A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Brief description of study

The purpose of the study is to evaluate the safety and efficacy of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive AVB-S6-500, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of AVB-S6-500, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy. The study drug AVB-S6-500 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s21-00831
ClinicalTrials.gov Identifier: NCT04983407


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