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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714190
• Other study ID #: RC48-C007
• Status: Recruiting
• Phase: Phase 3
• Start date: March 24, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: RemeGen Co., Ltd.
• Contact: Jianmin Fang, PhD
• Phone: 010-58075561
• Email: jianminfang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 351
• Est. completion date: June 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• HER2 Overexpressing Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• RC48-ADC
2.5 mg/kg IV every 2 weeks
• Paclitaxel injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
• Irinotecan Hydrochloride Injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
• Apatinib Mesylate Tablets
Administered according to label, as one option for Physician's Choice (determined before randomization)

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding
China	Beijing Cancer Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Luhe Hospital Affiliated to Capital Medical University	Beijing
China	Peking University People's Hospital	Beijing
China	Jilin Provincial Tumor Hospital	Changchun
China	Xiangya Hospital of Central South University	Changsha
China	Affiliated Hospital of Chengde Medical College	Chengde
China	Three Gorges Hospital Affiliated to Chongqing University	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	Southern Hospital of Southern Medical University	Guangzhou
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	The Affiliated Tumor Hospital of Harbin Medical University	Harbin
China	Anhui Cancer Hospital	Hefei
China	Anhui Provincial Hospital	Hefei
China	Jinan Central Hospital	Jinan
China	Shandong Cancer Hospital	Jinan
China	Affiliated Hospital of Jining Medical College	Jining
China	The First People's Hospital of Jining City	Jining
China	Lanzhou University Second Hospital	Lanzhou
China	Linyi Tumor Hospital	Linyi
China	Drum Tower Hospital Affiliated to Nanjing University School of Medicine	Nanjing
China	Jiangsu Cancer Hospital	Nanjing
China	The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)	Nanjing
China	Qingdao University Hospital	Qingdao
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Changhai Hospital	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai
China	Cancer Hospital Affiliated to Shantou University Medical College	Shantou
China	Liaoning Cancer Hospital	Shenyang
China	Shenzhen People's Hospital	Shenzhen
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Shanxi Cancer Hospital	Taiyuan
China	Tianjin Cancer Hospital	Tianjin
China	Weifang People's Hospital	Weifang
China	Weihai Municipal Hospital	Weihai
China	Huazhong University of Science Tongji Hospital, Tongji Medical College	Wuhan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Affiliated Hospital of Qinghai University	Xining
China	Qinghai Provincial People's Hospital	Xining
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Xuzhou Central Hospital	Xuzhou
China	Subei People's Hospital of Jiangsu Province	Yangzhou
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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	Progression-free survival (PFS), evaluated by the investigator	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
Secondary	Objective remission rate (ORR)	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
Secondary	Duration of relief (DOR)	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
Secondary	Disease control rate (DCR)	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
Secondary	Tumor progression time (TTP)	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