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OpenTrials
Completed

NCT Number: NCT01197885

Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MHAT "St.Marina", Varna, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
  • CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
  • At least 1 measurable site of disease according to RECIST criteria

Exclusion criteria

  • Less than 3 weeks since prior chemo-or radiation therapy
  • Other concurrent anticancer therapies
  • Concurrent anticoagulation with vitamin K antagonists
  • Therapeutic doses of Heparin (prophylactic doses accepted)
  • Uncontrolled or severe illness

Treatment and study plan

IMAB362

Drug

Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less

Primary outcomes

  1. Rate of remission (CR, PR) according to RECIST Criteria

    Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

Secondary outcomes

  1. Number of Participants with adverse events as a measure of safety and tolerability

    Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

  2. Frequency and severity of adverse events according to CTCAE v3.0

    Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

  3. Progression-free-survival time (PFS)

    Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

    The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)

Sponsors and collaborators

Lead sponsor

Ganymed Pharmaceuticals GmbH

Industry

Registry information

Official study title

International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2010
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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