計劃書編號CP-MGAH22-06
試驗已結束
2020-02-01 - 2026-12-31
Phase II/III
召募中5
A Phase 2/3 Trial to Evaluate Margetuximab in Combination withINCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients with Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
MacroGenics, Inc.
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臨床試驗規模
多國多中心
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更新日期
2026/04/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
HER2-positive Gastric Cancer and Gastroesophageal Junction Cancer
試驗目的
Primary objective
Cohort B, Part 1:
• To select the best margetuximab, chemotherapy and checkpoint inhibitor (CPI)-containing combination regimen for further evaluation in Part 2, based on evaluation of safety and ORR in the primary response evaluable population (PREP) of patients with GC or GEJ cancer, irrespective of PD-L1 status.
Cohort B, Part 2:
• To compare the overall survival (OS) of patients treated with the margetuximab, chemotherapy and CPI-containing arm selected from Cohort B, Part
藥品名稱
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主成份
Margetuximab (MGAH22)
MGA012 (INCMGA00012)
MGD013
MGA012 (INCMGA00012)
MGD013
劑型
27C
27C
27C
27C
27C
劑量
MG/ML
評估指標
Primary Outcome Measures :
1. Incidence of Adverse Events of margetuximab plus INCMGA00012 as assessed by CTCAE v5.0 [ Time Frame: 6 month intervals ]
Evaluation of adverse events and serious adverse events (Cohort A)
2. Objective response rate (ORR) [ Time Frame: 3 years ]
Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A and B)
3. Overall survival [ Time Frame: Up to 3 years ]
Time from randomization to death from any cause (Cohort B)
Secondary Outcome Measures :
4. Progression-free survival [ Time Frame: Up to 3 years ]
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 and B)
5. Duration of response [ Time Frame: Up to 3 years ]
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 and B)
6. Disease control rate [ Time Frame: Up to 3 years ]
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)
7. Patient reported quality of life [ Time Frame: Up to 3 years ]
Quality of life as assessed using the Functional Assessment of Cancer Therapy - Gastric Questionnaire (FACT-Ga) (Cohort B) on a scale of 0 to 184. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
1. Incidence of Adverse Events of margetuximab plus INCMGA00012 as assessed by CTCAE v5.0 [ Time Frame: 6 month intervals ]
Evaluation of adverse events and serious adverse events (Cohort A)
2. Objective response rate (ORR) [ Time Frame: 3 years ]
Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A and B)
3. Overall survival [ Time Frame: Up to 3 years ]
Time from randomization to death from any cause (Cohort B)
Secondary Outcome Measures :
4. Progression-free survival [ Time Frame: Up to 3 years ]
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 and B)
5. Duration of response [ Time Frame: Up to 3 years ]
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 and B)
6. Disease control rate [ Time Frame: Up to 3 years ]
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)
7. Patient reported quality of life [ Time Frame: Up to 3 years ]
Quality of life as assessed using the Functional Assessment of Cancer Therapy - Gastric Questionnaire (FACT-Ga) (Cohort B) on a scale of 0 to 184. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
主要納入條件
Key Inclusion Criteria:
• Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
1. Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%), and non-MSI-H per central review
2. Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
• 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
o Patients with MSI-H status by central test in Cohort A, or patients with known MSI-H status in Cohort B
• History of allogeneic stem cell or tissue/solid organ transplant
• Central nervous system metastases
• Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
o Prior neoadjuvant or adjuvant treatment with immunotherapy
• Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
1. Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%), and non-MSI-H per central review
2. Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
• 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
o Patients with MSI-H status by central test in Cohort A, or patients with known MSI-H status in Cohort B
• History of allogeneic stem cell or tissue/solid organ transplant
• Central nervous system metastases
• Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
o Prior neoadjuvant or adjuvant treatment with immunotherapy
試驗計畫預計收納受試者人數
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台灣人數
5 人
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全球人數
850 人
