Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
* Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
* CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
* Measurable and/or non-measurable disease as defined according to RECIST v1.1
* Age ≥ 18 years
* Written informed consent
* ECOG performance status (PS) 0-1
* Life expectancy \> 3 months

Exclusion Criteria:

* Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
* Known HIV infection or known symptomatic hepatitis (A, B, C)
* Clinical symptoms of cerebral metastases
* Pregnancy or breastfeeding
* Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
* Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium \< 8 mg/dl (2 mmol/L) or \> 12 mg/dL (3.0 mmol/L)