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

• Status: Completed
• Trial end date: 2014-10-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.; Ganymed Pharmaceuticals AG
• Treatments: Antibodies, Monoclonal; Diphosphonates; Interleukin-2; Zoledronic Acid

Criteria

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)