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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005509-64 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMAB362 + ZA | Experimental | Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1. |
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| IMAB362 + ZA + IL-2 (1 million IU) | 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. |
|
| IMAB362 + ZA + IL-2 (3 million IU) | 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. |
|
| IMAB362 | Active Comparator | Participants received IMAB362 only on Day 1 of each cycle every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMAB362 | Drug | 800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped. | at least 18 months |
| Immune cell profile and kinetics | Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients. | at least 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the time from registration of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation. | at least 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Klinische Forschung, Krankenhaus Nordwest GmbH | Frankfurt am Main | Hesse | 60488 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36607429 | Derived | Lordick F, Thuss-Patience P, Bitzer M, Maurus D, Sahin U, Tureci O. Immunological effects and activity of multiple doses of zolbetuximab in combination with zoledronic acid and interleukin-2 in a phase 1 study in patients with advanced gastric and gastroesophageal junction cancer. J Cancer Res Clin Oncol. 2023 Aug;149(9):5937-5950. doi: 10.1007/s00432-022-04459-3. Epub 2023 Jan 6. |
| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries 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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| Zoledronic acid | Drug | 4 mg on d 1 of cycle 1 and cycle 3 |
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| Interleukin-2 (1 million IU) | Drug | 1 million IU on day 1, 2 and 3 of cycles 1 and 3. |
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| Interleukin-2 (3 million IU) | Drug | 3 million IU on day 1, 2 and 3 of cycles 1 and 3. |
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| Objective tumor response rate (ORR) | ORR comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population. | at least 18 months |
| Disease control rate (DCR) | DCR is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population. | at least 18 months |
| Duration of response (DOR) | Duration of response is determined as the time when criteria for CR, PR, and SD are first met until the first date that recurrent or progressive disease or death occurs. | at least 18 months |
| BAG / Onkologische Schwerpunktpraxis |
| Dresden |
| Saxony |
| 01307 |
| Germany |
| Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie | Berlin | 13353 | Germany |
| Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology | Freiburg im Breisgau | 79106 | Germany |
| Leipzig University Hospital, University Cancer Center (UCCL) | Leipzig | 04109 | Germany |
| University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases | Tübingen | 72076 | Germany |
| Ulm University Hospital, Center for Internal Medicine | Ulm | 89070 | Germany |
| Piejuras Hospital, Oncology Clinic | Liepāja | 3401 | Latvia |
| Riga East University Hospital, LLC, Latvian Oncology Center | Riga | LV1038 | Latvia |
| ID | Term |
|---|---|
| C585662 | zolbetuximab |
| D000077211 | Zoledronic Acid |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
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