This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
AbGn-107 is an antibody drug conjugate (ADC) which targets an antigen (AG7 antigen) present in gastric, colorectal, pancreatic cancer or biliary cancer. This study is a standard 3 + 3 dose escalation design with cohort expansion. AbGn-107 will be administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic adenocarcinoma or biliary cancer. The primary objectives of this study are to define the safety profile and to determine the maximum tolerated dose regimen of AbGn-107, and the secondary objectives are to evaluate the pharmacokinetic (PK) parameters, the immunogenicity, and preliminary efficacy of AbGn-107.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Antibody Drug Conjugate
Mayo Clinic
Phoenix, Arizona, United States
University of California
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth-Israel Deaconess Medical Center
Adverse events (AEs) graded according to CTCAE v4.03.
Time frame: 28 days
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 70 days after treatment
Tmax (time from dosing to maximum measured concentration)
Time frame: 70 days after treatment
T1/2 (half-life of the analyte)
Time frame: 70 days after treatment
Immunogenicity evaluation based on anti-drug antibodies titer
Time frame: 70 days after treatment
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST)
Time frame: Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled
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Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington, United States
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan