A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

December 19, 2023 updated by: RemeGen Co., Ltd.

Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression

This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.

Study Type

Interventional

Enrollment (Estimated)

351

Phase

  • 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 Locations

  • China
      • Baoding, China
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Aimin Zang
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Yingjiang Ye
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Liqun Jia
      • Beijing, China
        • Recruiting
        • Luhe Hospital Affiliated to Capital Medical University
        • Contact:
          • Dong Yan
      • Changchun, China
        • Recruiting
        • Jilin Provincial Tumor Hospital
        • Contact:
          • Ying Cheng
      • Changsha, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Shan Zeng
      • Chengde, China
        • Recruiting
        • Affiliated Hospital of Chengde Medical College
        • Contact:
          • Qingshan Li
      • Chongqing, China
        • Recruiting
        • Three Gorges Hospital Affiliated to Chongqing University
        • Contact:
          • Jun Zhang
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Nanfeng Fan
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Shirong Cai
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Dong Ma
      • Guangzhou, China
        • Recruiting
        • Southern Hospital of Southern Medical University
        • Contact:
          • Min Shi
      • Guangzhou, China
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-Sen University
        • Contact:
          • Yanhong Deng
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Jie'er Ying
      • Hangzhou, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Nong Xu
      • Hangzhou, China
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Fuming Qiu
      • Harbin, China
        • Recruiting
        • The Affiliated Tumor Hospital of Harbin Medical University
        • Contact:
          • Yuxian Bai
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Yueyin Pan
      • Hefei, China
        • Recruiting
        • Anhui Cancer Hospital
        • Contact:
          • Yifu He
      • Jinan, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Changzheng Li
      • Jinan, China
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Meili Sun
      • Jining, China
        • Recruiting
        • Affiliated Hospital of Jining Medical College
        • Contact:
          • Lei Han
      • Jining, China
        • Recruiting
        • The First People's Hospital of Jining City
        • Contact:
          • Ning Liu
      • Lanzhou, China
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • hao Chen
      • Linyi, China
        • Recruiting
        • Linyi Tumor Hospital
        • Contact:
          • Zhen Li
      • Nanjing, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Jianwei Lu
      • Nanjing, China
        • Recruiting
        • Drum Tower Hospital affiliated to Nanjing University School of Medicine
        • Contact:
          • Jia Wei
      • Nanjing, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
        • Contact:
          • Yongqian Shu
      • Qingdao, China
        • Recruiting
        • Qingdao University Hospital
        • Contact:
          • Wensheng Qiu
      • Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Xianbao Zhan
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
          • Tianshu Liu
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
          • Jun Zhang
      • Shantou, China
        • Recruiting
        • Cancer Hospital affiliated to Shantou University Medical College
        • Contact:
          • Yi Jiang
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Jingdong Zhang
      • Shenzhen, China
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Ruilian Xu
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Kai Chen
      • Taiyuan, China
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Mudan Yang
      • Tianjin, China
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
          • Yi Ba
      • Weifang, China
        • Recruiting
        • Weifang People's Hospital
        • Contact:
          • Guohua Yu
      • Weihai, China
        • Recruiting
        • Weihai Municipal Hospital
        • Contact:
          • Airong Wang
      • Wuhan, China
        • Recruiting
        • Huazhong University of Science Tongji Hospital, Tongji Medical College
        • Contact:
          • Xianglin Yuan
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Enxiao Li
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Jiayi Li
      • Xining, China
        • Recruiting
        • Affiliated Hospital of Qinghai University
        • Contact:
          • Junhui Zhao
      • Xining, China
        • Recruiting
        • Qinghai provincial people's hospital
        • Contact:
          • Yujuan Qi
      • Xinxiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
          • Liuzhong Yang
      • Xuzhou, China
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Yuan Yuan
      • Xuzhou, China
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Chao Gao
      • Yangzhou, China
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
          • Xizhi Zhang
      • Yantai, China
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Liangming Zhang
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Suxia Luo
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • Male or female, Age ≥ 18 years.
  • Predicted survival ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  • Adequate organ function.
  • All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma
  • Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
  • The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
  • HER2 classic positive (definition: IHC3+ or IHC2+FISH+) and patients who have previously failed standard treatment
  • According to the RECIST 1.1 standard, there is at least one measurable lesion.

Exclusion Criteria:

  • Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • 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
Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Drug: RC48-ADC
2.5 mg/kg IV every 2 weeks
Other Names:
  • Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Active Comparator: Physician's Choice
Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Drug: Paclitaxel injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Names:
  • Taxol
Drug: Irinotecan Hydrochloride Injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Names:
  • CAMPTO
Drug: Apatinib Mesylate Tablets
Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Names:
  • Aitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: within approximately 3 years
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
within approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS), evaluated by the investigator
Time Frame: within approximately 3 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.
within approximately 3 years
Objective remission rate (ORR)
Time Frame: within approximately 3 years
The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).
within approximately 3 years
Duration of relief (DOR)
Time Frame: within approximately 3 years
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
within approximately 3 years
Disease control rate (DCR)
Time Frame: within approximately 3 years
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
within approximately 3 years
Tumor progression time (TTP)
Time Frame: within approximately 3 years
Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).
within approximately 3 years

Collaborators and Investigators

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

Sponsor

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)

March 24, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC48-C007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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