Clinical trial NCT04714190: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
HER2 Overexpressing Gastric Carcinoma
Keywords: RC48-ADC
HER2 overexpression
Gastric cancer
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: within approximately 3 years
Secondary outcomes:
measure: Progression-free survival (PFS), evaluated by the investigator
timeFrame: within approximately 3 years
measure: Objective remission rate (ORR)
timeFrame: within approximately 3 years
measure: Duration of relief (DOR)
timeFrame: within approximately 3 years
measure: Disease control rate (DCR)
timeFrame: within approximately 3 years
measure: Tumor progression time (TTP)
timeFrame: within approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Luhe Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: Jilin Provincial Tumor Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical College
city: Chongqing
country: China
facility: Three Gorges Hospital Affiliated to Chongqing University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Southern Hospital of Southern Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: The Affiliated Tumor Hospital of Harbin Medical University
city: Hefei
country: China
facility: Anhui Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Jinan
country: China
facility: Jinan Central Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
city: Jining
country: China
facility: The First People's Hospital of Jining City
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Linyi
country: China
facility: Linyi Tumor Hospital
city: Nanjing
country: China
facility: Drum Tower Hospital Affiliated to Nanjing University School of Medicine
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
city: Qingdao
country: China
facility: Qingdao University Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
city: Shantou
country: China
facility: Cancer Hospital Affiliated to Shantou University Medical College
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Weifang
country: China
facility: Weifang People's Hospital
city: Weihai
country: China
facility: Weihai Municipal Hospital
city: Wuhan
country: China
facility: Huazhong University of Science Tongji Hospital, Tongji Medical College
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu Province
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: