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| Name | Class |
|---|---|
| Zai Lab (Shanghai) Co., Ltd. | INDUSTRY |
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This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
Part A is a single-arm cohort (Cohort A, 40 to 110 participants) will evaluate safety and efficacy of margetuximab plus retifanlimab.
Part B Part 1 has 4 arms (50 patients/arm). Participants will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy-free arm | Experimental | margetuximab plus retifanlimab |
|
| Margetuximab, retifanlimab, and chemotherapy arm | Experimental | margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
|
| Margetuximab, tebotelimab and chemotherapy arm | Experimental | margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
|
| Margetuximab and chemotherapy arm | Experimental | margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
|
| Trastuzumab and chemotherapy arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| margetuximab | Biological | margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Evaluation of adverse events and serious adverse events (Cohort A) | Throughout the study, an average of 11 months. |
| Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews | Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment. CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as >= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing. CR + PR = ORR | Throughout the study, an average of 11 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A | Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A) based on investigator assessment | Throughout the study, an average of 11 months. |
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Key Inclusion Criteria:
Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing
Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1
Life expectancy ≥ 6 months
At least one radiographically measurable target lesion
Acceptable laboratory parameters and adequate organ function
Key Exclusion Criteria:
Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions
History of allogeneic stem cell or tissue/solid organ transplant
Central nervous system metastases
Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
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| Name | Affiliation | Role |
|---|---|---|
| Stephen L. Eck, MD, PhD | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| City of Hope Comprehensive Cancer Center - Duarte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41811823 | Derived | Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229. | |
| 33263418 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Chemotherapy-free Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. |
| FG001 | Part B: Margetuximab, Retifanlimab, and Chemotherapy Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Nov 25, 2024 |
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Cohort A is a single-arm cohort to evaluate safety and efficacy of margetuximab plus retifanlimab. Cohort B Part 1 is a randomized, 4-arm segment to evaluate margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab plus chemotherapy, margetuximab plus chemotherapy, vs trastuzumab plus chemotherapy.
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Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
|
|
| Retifanlimab | Biological | Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle. |
|
|
| Tebotelimab | Biological | Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle. |
|
|
| Trastuzumab | Biological | Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle |
|
|
| Chemotherapy | Other | Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 Chemotherapy XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion. |
|
| Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews |
Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A) |
| Throughout the study, an average of 11 months. |
| Disease Control Rate | Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B) | Throughout the study, an average of 11 months. |
| ORR for Cohort B | Proportion of participants with best overall response of CR plus PR per RECIST 1.1 | Throughout the study, an average of 11 months. |
| Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab | Throughout the study, an average of 11 months. |
| Number of Participants Who Have ADA to Retifanlimab | Throughout the study, an average of 11 months. |
| Number of Participants Who Have ADA to Tebotelimab | Throughout the study, an average of 11 months. |
| Duarte |
| California |
| 91010 |
| United States |
| Norris Comprehensive Cancer Center (USC) | Los Angeles | California | 90033 | United States |
| Salinas Memorial | Salinas | California | 93901 | United States |
| UCLA School of Medicine | Santa Monica | California | 90404 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Florida Cancer Specialists South | Fort Myers | Florida | 33901 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala | Ocala | Florida | 34474 | United States |
| Florida Cancer Specialists North | St. Petersburg | Florida | 33705 | United States |
| Kaiser Permanente | Honolulu | Hawaii | 96814 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Edward H. Kaplan MD & Associates | Skokie | Illinois | 60076 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Nebraska Heme Onc | Lincoln | Nebraska | 68506 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| The University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Stephenson Cancer Center at OUHSC | Oklahoma City | Oklahoma | 73104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Oncology Consultants | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Jilin Cancer Hospital (Second People's Hospital Of Jilin Province) | Changchun | 130000 | China |
| Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital) | Fuzhou | 350005 | China |
| SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine | Hangzhou | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin | Harbin | 150081 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | 230022 | China |
| Anhui Provincial Cancer Hospital | Hefei | 230031 | China |
| Jinan Center Hospital | Jinan | 250013 | China |
| Nanjing University Medical School; Nanjing Drug Tower | Nanjing | 210000 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200433 | China |
| Liaoning cancer hospital | Shenyang | 110042 | China |
| Hebei cancer hospital (The Fourth Affiliate) | Shijiazhuang | 050000 | China |
| Wuhan Union Hospital | Wuhan | 430022 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhenzhou | 450052 | China |
| Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF) | Frankfurt | 60488 | Germany |
| Haematologisch-Onkologische Praxis Eppendorf | Hamburg | Germany |
| Universitätsmedizin Mainz | Mainz | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | Germany |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Istituto Europeo Di Oncologia | Milan | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | 56126 | Italy |
| SPSK nr 1 in Lublin | Lublin | 20-081 | Poland |
| Centrum Medyczne MrukMed | Rzeszów | 35-922 | Poland |
| National University Hospital (Cancer Institute) -Singapore | Singapore | 119074 | Singapore |
| National Cancer Center Singapore | Singapore | 169610 | Singapore |
| Hallym University Sacred Heart Hospital | Anyang-si | 14068 | South Korea |
| CHA bundang | Gyeonggi-do | South Korea |
| Inje University Haeundae Paik Hospital | Haeundae | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Guro | Seoul | South Korea |
| Korea University, Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Yonsei University College of Medicine (Severance Hospital) | Seoul | South Korea |
| Catholic University of Korea St. Vincent Hospital | Suwon | South Korea |
| Taipei Medical University Hospital | Taipei City | Taipei | 110 | Taiwan |
| Kaohsiung Chang Gung MemorialHospital | Kaohsiung City | 83301 | Taiwan |
| Chang Gung Memorial Hospital, Keelung | Keelung | 204 | Taiwan |
| Liuying Chi MeiMedical Hospital | Tainan | 73657 | Taiwan |
| National Taiwan University | Taipei | Taiwan |
| Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital | Cambridge | United Kingdom |
| The Christie Hospital NHS Foundation Trust | Manchester | United Kingdom |
| Catenacci DV, Rosales M, Chung HC, H Yoon H, Shen L, Moehler M, Kang YK. MAHOGANY: margetuximab combination in HER2+ unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Apr;17(10):1155-1164. doi: 10.2217/fon-2020-1007. Epub 2020 Dec 2. |
margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6
| FG002 | Part B: Margetuximab, Tebotelimab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| FG003 | Part B: Margetuximab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| FG004 | Part B: Trastuzumab and Chemotherapy Arm | Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy-free Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. |
| BG001 | Margetuximab, Retifanlimab, and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| BG002 | Margetuximab, Tebotelimab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| BG003 | Margetuximab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| BG004 | Trastuzumab and Chemotherapy Arm | Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Evaluation of adverse events and serious adverse events (Cohort A) | All patients who receive at least one dose of study drug in Cohort A. | Posted | Count of Participants | Participants | Throughout the study, an average of 11 months. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews | Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment. CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as >= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing. CR + PR = ORR | All participants in Cohort A who received at least one dose of study treatment and had baseline radiographic tumor assessment. | Posted | Number | 95% Confidence Interval | percentage of participants with CR or PR | Throughout the study, an average of 11 months. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A | Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A) based on investigator assessment | All participants who were assigned to treatment in Cohort A. | Posted | Median | 95% Confidence Interval | months | Throughout the study, an average of 11 months. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews | Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A) | All participants in Cohort A who achieved a confirmed CR or PR. | Posted | Median | 95% Confidence Interval | months | Throughout the study, an average of 11 months. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B) | All participants in Cohort A and B who received at least one dose of study treatment and had baseline radiographic tumor assessment. | Posted | Number | 95% Confidence Interval | percent of participants | Throughout the study, an average of 11 months. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | ORR for Cohort B | Proportion of participants with best overall response of CR plus PR per RECIST 1.1 | All participants in Cohort B who received at least one dose of study treatment and had baseline radiographic tumor assessment. | Posted | Number | 95% Confidence Interval | percent of participants with CR+PR | Throughout the study, an average of 11 months. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab | Participants in Cohort A and B who received margetuximab as a component of study treatment. | Posted | Count of Participants | Participants | Throughout the study, an average of 11 months. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have ADA to Retifanlimab | Participants in Cohort A and B who received retifanlimab as a component of study treatment. | Posted | Count of Participants | Participants | Throughout the study, an average of 11 months. |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have ADA to Tebotelimab | Participants who received tebotelimab as a component of study treatment. | Posted | Count of Participants | Participants | Throughout the study, an average of 11 months. |
|
|
AEs are collected from the time of randomization throughout the safety follow up period, an average of 11 months.
AEs are based on physical exam, patient reports, and significant abnormal laboratory values.
Only patients who received study treatments were assessed for adverse events. Progression of cancer causing hospitalization or death is considered an efficacy outcome and not considered an SAE, unless considered drug-related by the investigator. The protocol-specific definition of an SAE excludes progression of cancer.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy-free Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. | 25 | 48 | 20 | 48 | 47 | 48 |
| EG001 | Margetuximab, Retifanlimab, and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Retifanlimab: 375 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 | 1 | 9 | 4 | 9 | 9 | 9 |
| EG002 | Margetuximab, Tebotelimab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 | 1 | 6 | 5 | 6 | 6 | 6 |
| EG003 | Margetuximab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 | 2 | 10 | 4 | 10 | 10 | 10 |
| EG004 | Trastuzumab and Chemotherapy Arm | Trastuzumab: 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 | 1 | 8 | 2 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment | Low neutrophil count with fever |
|
| Thyroiditis subacute | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment | Difficulty swallowing |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment | Painful intestinal obstruction |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment | Gas in the intestinal lining |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment | Fever |
|
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment | Weakness |
|
| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment | Gallbladder obstruction |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment | Gallbladder inflammation |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment | Severe bacterial infection |
|
| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment | Bladder inflammation |
|
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment | Severe infection |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Low potassium in the bloodstream |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Low bicarbonate in the blood |
|
| Malignant ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated renal disorder | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment | Lung inflammation |
|
| Combined pulmonary fibrosis and emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment | An accumulation of fluid around the lungs |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment | A flat red rash with raised areas |
|
| Influenza A | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment | Low white blood cells |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment | Low platelet level |
|
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment | Decreased thyroid function |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment | Indigestion |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment | Difficulty swallowing |
|
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment | Fever |
|
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment | Swelling in the extremities |
|
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment | Weakness |
|
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Decreased albumin in the bloodstream |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Decreased potassium in the bloodstream |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Decreased sodium in the bloodstream |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment | Decreased calcium in the bloodstream |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment | Joint pains |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment | Difficulty breathing |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment | Nosebleed |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment | Runny nose |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment | Itching |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment | Redness, pain or swelling of the palms and soles of the feet. |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment | A flat red rash with raised areas |
|
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment | High blood pressure |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | MacroGenics, Inc. | 301-251-5172 | info@macrogenics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2022 | Nov 21, 2024 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000617981 | margetuximab |
| D000068878 | Trastuzumab |
| D004358 | Drug Therapy |
| 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 |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Singapore |
|
| United States |
|
| China |
|
| Taiwan |
|
| Poland |
|
| Italy |
|
| United Kingdom |
|
| Title | Measurements |
|---|---|
|
| severe treatment-related AE |
|
| AE resulting in whole study treatment withdrawal |
|
|
|
|
| Margetuximab, Tebotelimab and Chemotherapy Arm |
margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Tebotelimab: 600 mg IV, Day 1 of each 3-week cycle. Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
| OG004 | Margetuximab and Chemotherapy Arm | margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
|
|
| Margetuximab and Chemotherapy Arm |
margetuximab: 15 mg/kg IV, Day1 of each 3-week cycle Chemotherapy: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 |
|
|
|
|
|
| Title | Denominators | Categories | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|