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This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC48-ADC+Toripalimab+CAPOX (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
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| RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and Trastuzumab every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
|
| RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression) | Experimental | Participants with HER2-intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC48-ADC（2.5mg/kg） | Drug | 2.5 mg/kg intravenous infusion every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety(adverse event) | to evaluate safety including adverse event rate and adverse event grade. | Up to approximately 2 years |
| Progression-free survival (PFS), evaluated by the investigator | Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Su, PhD | RemeGen Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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| Toripalimab+Trastuzumab+CAPOX (HER2-high expression) | Active Comparator | Participants with HER2-high expression (IHC2+FISH+ or IHC3+) will receive of Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
|
| Toripalimab+CAPOX (HER2- intermediate/low expression) | Active Comparator | Participants with HER2- intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
|
| RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and Capecitabine every 3 weeks (Q3W), as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
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| RC48-ADC+Toripalimab+CAPOX (HER2-negative) | Experimental | Participants with HER2-negative (IHC0) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
|
| Toripalimab+CAPOX (HER2- negative) | Active Comparator | Participants with HER2- negative (IHC 0) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
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| Trastuzumab | Drug | First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks |
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| Toripalimab | Drug | 3.0 mg/kg intravenous infusion every 2 weeks |
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| Oxaliplatin（130mg/m2 ） | Drug | 130mg/m2 intravenous infusion Q3W |
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| Capecitabine（1000mg/m2） | Drug | 1000mg/m2 per os Q3W |
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| RC48-ADC（2.0mg/kg） | Drug | 2.0 mg/kg intravenous infusion every 2 weeks |
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| Capecitabine（750mg/m2） | Drug | 750mg/m2 per os Q3W |
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| Oxaliplatin（100mg/m2 ） | Drug | 100mg/m2 intravenous infusion Q3W |
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| Up to approximately 2 years |
| Overall survival (OS) | Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject. | Up to approximately 2 years |
| Duration of response (DOR) | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death | Up to approximately 2 years |
| Disease Control Rate(DCR) | DCR is the proportion of subjects with optimal overall response to achieve objective remission or stable disease over the course of the study | Up to approximately 2 years |
| 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 |
|---|---|
| C000722994 | disitamab vedotin |
| D000068878 | Trastuzumab |
| C000656314 | toripalimab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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