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

NCT01671774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-11-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-16
Primary Completion
2014-10-13
Completion
2014-10-13

Countries

  • Germany
  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671774 on ClinicalTrials.gov