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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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ClinicalTrials.gov Identifier: NCT03556345
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer HER2 Overexpressing Gastric Carcinoma Drug: RC48-ADC Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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 Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate （ORR） [ Time Frame: up to 24 months ]
    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) as Assessed by investigator [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1

  2. Overall Survival(OS) [ Time Frame: up to 24 months ]
    OS was defined as the time from the first study treatment to the date of death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556345


Contacts
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Contact: Jianmin Fang 010-58075561 jianminfang@hotmail.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lin Shen    010-53806898    linshenpku@163.com   
Sponsors and Collaborators
RemeGen
More Information
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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT03556345     History of Changes
Other Study ID Numbers: RC48-C008
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RemeGen:
RC48-ADC
HER2 overexpression
Gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Trastuzumab
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents