Spots Global Cancer Trial Database for A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
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Trial Identification
Brief Title: A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
Official Title: A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer
Study ID: NCT02908451
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Contact Details
Name: Shih-Yao (David) Lin, MD, PhD
Affiliation: AbGenomics B.V.
Role: STUDY_DIRECTOR
Name: Andrew Ko, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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