Protocol #: 17-137
Status
Recruiting
Description
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.
Condition
Gastric Cancer
Colorectal Cancer
Pancreatic Cancer
Biliary Cancer
Interventions
AbGn-107
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Adverse events (AEs) graded according to CTCAE v4.03.
Secondary Outcome:
Cmax (maximum measured concentration of the analyte in plasma)
Tmax (time from dosing to maximum measured concentration)
T1/2 (half-life of the analyte)
Immunogenicity evaluation based on anti-drug antibodies titer
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST)
Estimated Enrollment
136
Study Start Date
April 24, 2017
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
AbGenomics B.V Taiwan Branch
Information Provided By
AbGenomics B.V Taiwan Branch
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
Clinicaltrials.gov Identifier
NCT02908451

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

Back to Top