A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression
1 other identifier
interventional
201
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2023
CompletedStudy Start
First participant enrolled
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2026
ExpectedSeptember 29, 2025
September 1, 2025
1.9 years
July 1, 2023
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Safety(adverse event)
Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Up to approximately 2 years
Overall survival (OS)
Up to approximately 2 years
Duration of response (DOR)
Up to approximately 2 years
Disease Control Rate(DCR)
Up to approximately 2 years
Study Arms (8)
RC48-ADC+Toripalimab+CAPOX (HER2-high expression)
EXPERIMENTALParticipants 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+Toripalimab+Trastuzumab (HER2-high expression)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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).
Toripalimab+Trastuzumab+CAPOX (HER2-high expression)
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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)
EXPERIMENTALParticipants 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+Toripalimab+CAPOX (HER2-negative)
EXPERIMENTALParticipants 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 COMPARATORParticipants 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).
Interventions
2.5 mg/kg intravenous infusion every 2 weeks
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
3.0 mg/kg intravenous infusion every 2 weeks
130mg/m2 intravenous infusion Q3W
1000mg/m2 per os Q3W
2.0 mg/kg intravenous infusion every 2 weeks
750mg/m2 per os Q3W
100mg/m2 intravenous infusion Q3W
Eligibility Criteria
You may qualify if:
- Voluntary agreement to provide written informed consent.
- 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.
You may not qualify if:
- Active central nervous system (CNS) metastases.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Na Su, PhD
RemeGen Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2023
First Posted
August 8, 2023
Study Start
August 4, 2023
Primary Completion
July 10, 2025
Study Completion (Estimated)
October 10, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09