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
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)