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出境医 / 临床实验 / KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

Study Description
Brief Summary:
This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.

Condition or disease Intervention/treatment Phase
Gastric/Gastroesophageal Junction Cancer Drug: KN026 10 mg/kg QW Drug: KN026 20 mg/kg Q2W Drug: KN026 30 mg/kg Q3W Phase 2

Detailed Description:
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: HER2 overexpression
HER2 IHC 3+ or IHC2+ and ISH+
 Drug: KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage

Drug: KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage

Drug: KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage
Experimental: HER2 expression
HER2 IHC 2+ISH- or IHC 1+ and ISH+
 Drug: KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage

Drug: KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage

Drug: KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage
Outcome Measures
Primary Outcome Measures :
  1. ORR [ Time Frame: 1 years ]
    clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria

  2. DOR [ Time Frame: 1 years ]
    clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed inform consent form(ICF)
  • Age ≥ 18 years and ≤ 75 years, male or female
  • Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ & ISH+ HER2 expressing: IHC2+ & ISH- or IHC 1+ & ISH+
  • Received at least one prior standard therapy
  • At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • LVEF≥ 50% (ECHO)
  • Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
  • Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

  • Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
  • Accepted radiotherapy within 4 weeks before enrollment
  • An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
  • Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
  • Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
  • History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  • Severe chronic and active infection, need to system antibiosis/antiviral treatment
  • Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
  • Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
Contacts and Locations

Locations
Layout table for location information
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China
Contact: Yun Zhang, MD    86-10-66947798    zhangyun198728@163.com   
Sponsors and Collaborators
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • ORR [ Time Frame: 1 years ]
    clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
  • DOR [ Time Frame: 1 years ]
    clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • ORR [ Time Frame: 1 years ]
    clinical response rate (ORR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria
  • DOR [ Time Frame: 1 years ]
    clinical response time (DOR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer
Official Title  ICMJE Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
Brief Summary This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
Detailed Description The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric/Gastroesophageal Junction Cancer
Intervention  ICMJE
  • Drug: KN026 10 mg/kg QW
    10 mg/kg QW as safety run-in dosage
  • Drug: KN026 20 mg/kg Q2W
    20 mg/kg Q2W as target dosage
  • Drug: KN026 30 mg/kg Q3W
    30 mg/kg Q3W as another target dosage
Study Arms  ICMJE
  • Experimental: HER2 overexpression
    HER2 IHC 3+ or IHC2+ and ISH+
    Interventions:
    • Drug: KN026 10 mg/kg QW
    • Drug: KN026 20 mg/kg Q2W
    • Drug: KN026 30 mg/kg Q3W
  • Experimental: HER2 expression
    HER2 IHC 2+ISH- or IHC 1+ and ISH+
    Interventions:
    • Drug: KN026 10 mg/kg QW
    • Drug: KN026 20 mg/kg Q2W
    • Drug: KN026 30 mg/kg Q3W
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2020) 		50
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		40
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed inform consent form(ICF)
  • Age ≥ 18 years and ≤ 75 years, male or female
  • Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ & ISH+ HER2 expressing: IHC2+ & ISH- or IHC 1+ & ISH+
  • Received at least one prior standard therapy
  • At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • LVEF≥ 50% (ECHO)
  • Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
  • Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

  • Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
  • Accepted radiotherapy within 4 weeks before enrollment
  • An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
  • Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
  • Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
  • History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  • Severe chronic and active infection, need to system antibiosis/antiviral treatment
  • Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
  • Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925974
Other Study ID Numbers  ICMJE KN026-202
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study Sponsor  ICMJE Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Verification Date July 2020

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

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