Title
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
Phase
Phase 1Lead Sponsor
Ganymed Pharmaceuticals AGStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Solid TumorsIntervention/Treatment
claudiximab ...Study Participants
15Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma
Patients receive Claudiximab as intravenous infusion over 2 hours on day 1. Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT. After completion of study treatment, patients are followed for 4 weeks.
Inclusion Criteria: Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology CLDN18.2 expression confirmed by immunohistochemistry Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry) Age ≥ 18 years ECOG performance status (PS) 0-1 or Karnofsky Index 70-100% Life expectancy > 3 months Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dl INR < 1.5 Bilirubin normal AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Creatinine < 1.5 x ULN Exclusion Criteria: Pregnancy or breastfeeding Prior allergic reaction or intolerance to a monoclonal antibody Prior inclusion in the present study Less than 3 weeks since prior anti-tumor or radiation therapy Other investigational agents or devices concurrently or within 4 weeks prior to this study Other concurrent anticancer therapies History of positive test for human immunodeficiency virus (HIV) antibody Known Hepatitis. Uncontrolled or severe illness. Concurrent administration of anticoagulation agents with vitamin K antagonists Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
