NCT01671774

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

Multicenter, Open-label, Exploratory Phase I Pilot Study to Investigate Safety, Pharmacodynamics, and Pharmacokinetics of Immunological Effects and Activity of Combining Multiple Doses of IMAB362 With Immunomodulation (Zoledronic Acid, Interleukin-2) in Patients With Advanced Adenocarcinoma of the Stomach, the Lower Esophagus, or the Gastroesophageal Junction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CLDN18.2-positive Gastric Adenocarcinoma
• CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
• CLDN18.2-positive Adenocarcinoma of Esophagus

Interventions

Type	Name	Description
DRUG	IMAB362	800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
DRUG	Zoledronic acid	4 mg on d 1 of cycle 1 and cycle 3
DRUG	Interleukin-2 (1 million IU)	1 million IU on day 1, 2 and 3 of cycles 1 and 3.
DRUG	Interleukin-2 (3 million IU)	3 million IU on day 1, 2 and 3 of cycles 1 and 3.

Timeline

• Start date: 2012-10-16
• Primary completion: 2014-10-13
• Completion: 2014-10-13
• First posted: 2012-08-24
• Last updated: 2024-11-14

Locations

9 sites across 2 countries: Germany, Latvia