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

• ClinicalTrials.gov Identifier: NCT01197885
• Recruitment Status: Completed
• First Posted: September 9, 2010
• Last Update Posted: July 2, 2017
• Sponsor: Ganymed Pharmaceuticals GmbH
• Information provided by (Responsible Party): Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )

Tracking Information

• First Submitted Date: September 6, 2010
• First Posted Date: September 9, 2010
• Last Update Posted Date: July 2, 2017
• Study Start Date: September 2010
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 8, 2010): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2010)

• 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 ]
• 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 ]
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
• Official 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors

Intervention

Drug: IMAB362

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

Study Arms

Experimental: IMAB362

Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.

Intervention: Drug: IMAB362

• Publications *: Tureci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. Ann Oncol. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 10, 2012): 54
• Original Estimated Enrollment (submitted: September 8, 2010): 25
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Germany, Latvia, Lithuania, Switzerland
• Removed Location Countries: Austria

Administrative Information

• NCT Number: NCT01197885
• Other Study ID Numbers: GM-IMAB-001-02; 2009-017365-36 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )
• Original Responsible Party: Eveline Förster, Manager Clinical Research, Ganymed Pharmaceuticals AG
• Current Study Sponsor: Ganymed Pharmaceuticals GmbH
• Original Study Sponsor: Ganymed Pharmaceuticals AG
• Collaborators: Not Provided

Investigators

• Principal Investigator: Martin Schuler, Prof. Dr. med.; Innere Klinik Universitätsklinikum Essen

• PRS Account: Astellas Pharma Inc
• Verification Date: December 2015