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KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03847168
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Tracking Information
First Submitted Date  ICMJE February 18, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
The proportion of patients experiencing dose limiting toxicities [ Time Frame: From screening to up to 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest [ Time Frame: From screening to up to 196 days ]
  • Maximum observed serum concentration (Cmax) of KN026 [ Time Frame: Throughout the duration of the study; up to 84 days ]
  • Time of Maximum observed serum concentration (Tmax) of KN026 [ Time Frame: Throughout the duration of the study; up to 84 days ]
  • Frequency and titer of anti-KN026 antibody [ Time Frame: Throughout the duration of the study; up to 2 years ]
  • The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria [ Time Frame: Throughout the duration of the study; up to 2 years ]
  • Progression free survival according to RECIST 1.1 criteria [ Time Frame: Throughout the duration of the study; up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
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 Breast Cancer and Gastric Cancer
Official Title  ICMJE Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors
Brief Summary This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 3 proposed dose levels which are 10, 15, and 20 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Gastric/Gastroesophageal Junction Cancer
Intervention  ICMJE Drug: KN026
Patient will be intravenously administrated with one dose of KN026 every week or every other week.
Study Arms  ICMJE Experimental: KN026
Patient will be intravenously administrated with one dose of KN026. Dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.
Intervention: Drug: KN026
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: February 18, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject >= 18 years
  • Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
  • ECOG score 0 or 1
  • Life expectancy >3 months
  • According to the definition of RECIST1.1, the patient has at least one measurable lesion
  • Adequate organ function prior to start treatment with KN026
  • Able to understand, voluntarily participate and willing to sign the ICF
  • Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

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 300 mg/m² within 90 days before first KN026 dosing, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03847168
Other Study ID Numbers  ICMJE KN026-US-I-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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