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Brief Title: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
Official Title: A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Study ID: NCT04983407
Brief Summary: This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept 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 batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Health, Santa Monica, California, United States
Boca Raton Regional Hospital / Lynn Cancer Institute, Boca Raton, Florida, United States
Moffit Cancer Center, Tampa, Florida, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Michigan Medicine - University of Michigan, Ann Arbor, Michigan, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Duke University Medical Center (DUMC), Durham, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University / Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States