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NCT Number: NCT05980481

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Cancer Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RC48-ADC（2.5mg/kg）

Drug

2.5 mg/kg intravenous infusion every 2 weeks

Other names: Disitamab Vedotin

Trastuzumab

Drug

First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks

Other names: Trastuzumab Injection

Toripalimab

Drug

3.0 mg/kg intravenous infusion every 2 weeks

Other names: JS001

Oxaliplatin（130mg/m2 ）

Drug

130mg/m2 intravenous infusion Q3W

Other names: Oxaliplatin injection

Capecitabine（1000mg/m2）

Drug

1000mg/m2 per os Q3W

Other names: Capecitabine Tablets

RC48-ADC（2.0mg/kg）

Drug

2.0 mg/kg intravenous infusion every 2 weeks

Other names: Disitamab Vedotin

Capecitabine（750mg/m2）

Drug

750mg/m2 per os Q3W

Other names: Capecitabine Tablets

Oxaliplatin（100mg/m2 ）

Drug

100mg/m2 intravenous infusion Q3W

Other names: Oxaliplatin injection（100mg/m2 ）

Primary outcomes

  1. 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).

Secondary outcomes

  1. Safety(adverse event)

    Time frame: Up to approximately 2 years

    to evaluate safety including adverse event rate and adverse event grade.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

RemeGen Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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