A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

September 23, 2025 updated by: RemeGen Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 participants with locally advanced or metastatic gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.

Study Type

Interventional

Enrollment (Estimated)

201

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Experimental: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Other Names:
  • Trastuzumab Injection
Experimental: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Drug: RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Drug: Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection（100mg/m2 ）
Active Comparator: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Drug: Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Other Names:
  • Trastuzumab Injection
Active Comparator: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Experimental: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Drug: Trastuzumab
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
Other Names:
  • Trastuzumab Injection
Experimental: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: RC48-ADC（2.5mg/kg）
2.5 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: RC48-ADC（2.0mg/kg）
2.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • Disitamab Vedotin
Drug: Capecitabine（750mg/m2）
750mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets
Drug: Oxaliplatin（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection（100mg/m2 ）
Active Comparator: 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).
Drug: Toripalimab
3.0 mg/kg intravenous infusion every 2 weeks
Other Names:
  • JS001
Drug: Oxaliplatin（130mg/m2 ）
130mg/m2 intravenous infusion Q3W
Other Names:
  • Oxaliplatin injection
Drug: Capecitabine（1000mg/m2）
1000mg/m2 per os Q3W
Other Names:
  • Capecitabine Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety(adverse event)
Time Frame: Up to approximately 2 years
to evaluate safety including adverse event rate and adverse event grade.
Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Time Frame: Up to approximately 2 years
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.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years
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
Disease Control Rate(DCR)
Time Frame: Up to approximately 2 years
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
Duration of response (DOR)
Time Frame: Up to approximately 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RemeGen Co., Ltd.

Investigators

  • Study Director: Na Su, PhD, RemeGen Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2023

Primary Completion (Actual)

July 10, 2025

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

July 1, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC48-C027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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