Back to resultsA Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
Primary Purpose
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC48-ADC
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring RC48-ADC, HER2 overexpression, Gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years and ≤ 80 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.
- Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
- HER2 overexpression defined as HER2 IHC 2+ or 3+.
- Measurable disease according to RECIST 1.1.
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.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RC48-ADC
Arm Description
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).
Outcomes
Primary Outcome Measures
Objective Response Rate （ORR）
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Secondary Outcome Measures
Progression Free Survival (PFS) as Assessed by investigator
Tumor response was assessed by investigator according to RECIST v1.1
Overall Survival(OS)
OS was defined as the time from the first study treatment to the date of death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03556345
Brief Title
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
Official Title
A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in HER2 Overexpressing Local Advanced or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
Keywords
RC48-ADC, HER2 overexpression, Gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RC48-ADC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
RC48-ADC
Other Intervention Name(s)
Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Intervention Description
2.5 mg/kg IV every 2 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate （ORR）
Description
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Assessed by investigator
Description
Tumor response was assessed by investigator according to RECIST v1.1
Time Frame
up to 24 months
Title
Overall Survival(OS)
Description
OS was defined as the time from the first study treatment to the date of death from any cause
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary agreement to provide written informed consent.
Male or female, Age ≥ 18 years and ≤ 80 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.
Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
HER2 overexpression defined as HER2 IHC 2+ or 3+.
Measurable disease according to RECIST 1.1.
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.
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34665942
Citation
Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Nov;41(11):1173-1182. doi: 10.1002/cac2.12214. Epub 2021 Oct 19.
Results Reference
derived
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A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
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