Completed

PILOTMulticenter, 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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

IMAB362

+ Zoledronic acid

+ IMAB362

Drug
Who is being recruted

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorAstellas Pharma Global Development, Inc.
Last updated: November 14, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: October 16, 2012

Actual date on which the first participant was enrolled.

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.

NCT01671774
Principal SponsorAstellas Pharma Global Development, Inc.
Last updated: November 14, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Age >= 18 years
CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample
ECOG performance status (PS) 0-1
Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
Show More Criteria
6 exclusion criteria prevent from participating
Clinical symptoms of cerebral metastases
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)
Known HIV infection or known symptomatic hepatitis (A, B, C)
Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.

Group II

Experimental
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.

Group III

Experimental
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.

Group IV

Active Comparator
Participants received IMAB362 only on Day 1 of each cycle every 3 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Institut für Klinische Forschung, Krankenhaus Nordwest GmbH

Frankfurt am Main, GermanyOpen Institut für Klinische Forschung, Krankenhaus Nordwest GmbH in Google Maps

BAG / Onkologische Schwerpunktpraxis

Dresden, Germany

Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie

Berlin, Germany

Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology

Freiburg im Breisgau, Germany
Completed9 Study Centers