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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lin Shen, PHD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RemeGen Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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