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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017365-36 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMAB362 | Experimental | Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of remission (CR, PR) according to RECIST Criteria | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse events as a measure of safety and tolerability | 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 | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schuler, Prof. Dr. med. | Innere Klinik Universitätsklinikum Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Dispensary "Dr. Marko Markov" | Varna | 9002 | Bulgaria | |||
| MHAT "St.Marina" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31240302 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| Progression-free-survival time (PFS) | The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first) | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion |
| Varna |
| 9010 |
| Bulgaria |
| Complex Oncology Center | Veliko Tarnovo | 5000 | Bulgaria |
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Medizinische Univeritätsklinik Ruhr-Universität Bochum | Bochum | 44892 | Germany |
| Klinikum Braunschweig | Braunschweig | 38114 | Germany |
| Universitätsklinikum Essen, Innere Klinik (Tumorforschung) | Essen | 45122 | Germany |
| Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie | Frankfurt | 60488 | Germany |
| Universitätsklinikum Halle | Halle | 06120 | Germany |
| Universitäres Cancer Center Universitätsklinikum Eppendorf | Hamburg | 20246 | Germany |
| Onkologische Schwerpunktpraxis Eppendorf | Hamburg | 20249 | Germany |
| Universitätsklinikum Heidelberg, NCT | Heidelberg | 69120 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Universitätsmedizin der Johannes-Gutenberg Universität | Mainz | 55101 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Piejuras Hospital | Liepāja | Latvia |
| Paula Stradina Clinical University Hospital | Riga | 1002 | Latvia |
| Riga East Clinical Research | Riga | 1038 | Latvia |
| Vilnius University | Vilnius | 08660 | Lithuania |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| Updated Vivli Worksheet | View source |
| ID | Term |
|---|---|
| C585662 | zolbetuximab |
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