A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
NCT ID: NCT05980481
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
201 participants
INTERVENTIONAL
2023-08-04
2026-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RC48-ADC+Toripalimab+CAPOX (HER2-high expression)
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).
RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression)
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（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression)
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).
RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Toripalimab+Trastuzumab+CAPOX (HER2-high expression)
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).
Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Toripalimab+CAPOX (HER2- intermediate/low expression)
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).
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression)
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).
RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC+Toripalimab+CAPOX (HER2-negative)
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).
RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Toripalimab+CAPOX (HER2- negative)
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).
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Interventions
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RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age:18-75 years（including 18 and 75）.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function.
* All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma.
* Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted;
* HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+ or IHC0.
Exclusion Criteria
* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.
* Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Na Su, PhD
Role: STUDY_DIRECTOR
RemeGen Co., Ltd.
Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Other Identifiers
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RC48-C027
Identifier Type: -
Identifier Source: org_study_id
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