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出境医 / 临床实验 / A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Study Description
Brief Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Advanced Cancer Drug: RC48-ADC Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Drug: RC48-ADC
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 Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018
Arms and Interventions
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 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Outcome Measures
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. ORR of HER2-positive patients [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1

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

  3. Duration of Response (DOR) [ Time Frame: up to 24 months ]
    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier

  4. Disease control rate (DCR) [ Time Frame: up to 24 months ]
    DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study

  5. 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

  6. Adverse Events [ Time Frame: 28 days after the last dose of study treatment ]
    Incidence of Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 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.
  • Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
  • Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
  • Adequate organ function, evidenced by the following laboratory results:

Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.

  • 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.

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 receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • 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.
  • Currently known active infection with HIV or tuberculosis.
  • 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.
  • known central nervous system metastases.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Contacts and Locations

Locations
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China, N/A = Not Applicable
Beijing Cancer Hospital
Beijing, N/A = Not Applicable, China, 100078
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, N/A = Not Applicable, China
Sponsors and Collaborators
RemeGen Co., Ltd.
Tracking Information
First Submitted Date  ICMJE April 8, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE December 28, 2017
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2018) 		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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • ORR of HER2-positive patients [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1
  • Progression Free Survival (PFS) [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1
  • Duration of Response (DOR) [ Time Frame: up to 24 months ]
    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
  • Disease control rate (DCR) [ Time Frame: up to 24 months ]
    DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study
  • 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
  • Adverse Events [ Time Frame: 28 days after the last dose of study treatment ]
    Incidence of Adverse Events
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2018)
  • 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
  • Duration of Objective Response (DOR) [ Time Frame: up to 24 months ]
    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Official Title  ICMJE 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 Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Brief Summary This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Drug: RC48-ADC
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urothelial Carcinoma
  • Advanced Cancer
Intervention  ICMJE Drug: RC48-ADC
2 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Study Arms  ICMJE 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).
Intervention: Drug: RC48-ADC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019) 		43
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2018) 		60
Actual Study Completion Date  ICMJE October 29, 2018
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • Male or female, Age ≥ 18 years and < 80 years.
  • Predicted survival ≥ 12 weeks.
  • Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
  • Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
  • Adequate organ function, evidenced by the following laboratory results:

Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.

  • 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.

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 receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • 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.
  • Currently known active infection with HIV or tuberculosis.
  • 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.
  • known central nervous system metastases.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507166
Other Study ID Numbers  ICMJE RC48-C005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RemeGen Co., Ltd.
Study Sponsor  ICMJE RemeGen Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RemeGen Co., Ltd.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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