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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Batiraxcept is experimental drug
Nab paclitaxel is active comparator
Gemcitabine is active comparator
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
...and 7 more locations
Incidence of adverse events (AEs)
Measured by the number of patients with AEs in Phase 1b portion of the study.
Time frame: 12 months
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study.
Time frame: 12 months
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study
Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.
Time frame: 30 months
Pharmacokinetics: AUC
Area under the batiraxcept concentration-time curve.
Time frame: 30 months
Pharmacokinetics: Cmax
Maximum observed batiraxcept concentration.
Time frame: 30 months
Pharmacokinetics: Tmax
Time of maximum observed batiraxcept concentration.
Time frame: 30 months
Pharmacokinetics: t1/2
Apparent terminal half-life of batiraxcept.
Time frame: 30 months
Pharmacodynamic marker assessment
Change from the baseline in GAS6 serum levels.
Time frame: 30 months
Anti-drug antibody (ADA) titers
Change from baseline in ADA titer.
Time frame: 30 months
Disease control rate
Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Time frame: 30 months
Duration of response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses.
Time frame: 30 months
Overall survival
Time following the treatment until death.
Time frame: 60 months
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