A Phase 2 Study of IMAB362 as Monotherapy or in Combination With mFOLFOX6 in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Whose Tumors Have High or Intermediate Claudin (CLDN) 18.2 Expression
Bert O'Neil, MD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Gastric Cancer,stomach cancer,Gastro-esophageal Junction (GEJ) Cancer
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Has histologically confirmed gastric or GEJ adenocarcinoma
Exclusion Criteria
Has had prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies
Has known immediate or delayed hypersensitivity or contraindication to any component of study treatment
Has gastric outlet syndrome or persistent recurrent vomiting
Has known active central nervous system metastases and/or carcinomatous meningitis
Has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection
Has active infection requiring systemic therapy
Has active autoimmune disease that has required systemic treatment in the past 2 years