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The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort A: Bemarituzumab with CAPOX | Experimental |
| |
| Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab | Experimental |
| |
| Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab | Experimental |
| |
| Part 2: Bemarituzumab with SOX and Nivolumab. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemarituzumab | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) | Day 1 up to Day 21 | |
| Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | Day 1 to end of treatment (up to approximately 1 year) | |
| Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 30 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab | Day 1 to end of treatment (up to approximately 1 year) | |
| Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab | Day 1 to end of treatment (up to approximately 1 year)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northport Veterans Affairs Medical Center | Northport | New York | 11768 | United States | ||
| Fujita Health University Hospital |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| CAPOX | Drug | CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets. |
|
| SOX | Drug | SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally. |
|
| Nivolumab | Drug | IV infusion. |
|
| Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab | Day 1 to end of treatment (up to approximately 1 year) |
| Part 1: OR per RECIST v1.1 | Up to 2 years |
| Part 1: Duration of Response (DoR) per RECIST v1.1 | Up to 2 years |
| Part 1: Disease Control Rate (DCR) | Up to 2 years |
| Part 1: Progression-free Survival (PFS) per RECIST v1.1 | Up to 2 years |
| Part 1: Overall Survival (OS) | Up to 2 years |
| Part 2: Number of Participants Who Experience TEAEs | Up to 30 months |
| Part 2: DoR per RECIST v1.1 | Up to 30 months |
| Part 2: Time to Response (TTR) per RECIST v1.1 | Up to 30 months |
| Part 2: Disease Control (DC) per RECIST v1.1 | Up to 30 months |
| Part 2: PFS per RECIST v1.1 | Up to 30 months |
| Part 2: OS | Up to 30 months |
| Toyoake-shi |
| Aichi-ken |
| 470-1192 |
| Japan |
| Hirosaki University Hospital | Hirosaki-shi | Aomori | 036-8563 | Japan |
| Chiba University Hospital | Chiba | Chiba | 260-8677 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Fukui Prefectural Hospital | Fukui-shi | Fukui | 910-8526 | Japan |
| Kyushu University Hospital | Fukuoka | Fukuoka | 812-8582 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| Ogaki Municipal Hospital | Ogaki-shi | Gifu | 503-8502 | Japan |
| Gunma University Hospital | Maebashi | Gunma | 371-8511 | Japan |
| Gunma Prefectural Cancer Center | Ota-shi | Gunma | 373-8550 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Ibaraki Prefectural Central Hospital | Kasama-shi | Ibaraki | 309-1793 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| St Marianna University Hospital | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Kochi Health Sciences Center | Kochi | Kochi | 781-8555 | Japan |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka General Medical Center | Osaka | Osaka | 558-8558 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Shizuoka General Hospital | Shizuoka | Shizuoka | 420-8527 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| IMSUT Hospital, The Institute of Medical Science The University of Tokyo | Minato-ku | Tokyo | 108-8639 | Japan |
| Toyama University Hospital | Toyama | Toyama | 930-0194 | Japan |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Center | Goyang-si Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000714767 | bemarituzumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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