Clinical Trials /

KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

NCT03847168

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
  • Official Title: Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: KN026-US-I-001
  • NCT ID: NCT03847168

Conditions

  • Breast Cancer
  • Gastric/Gastroesophageal Junction Cancer

Interventions

DrugSynonymsArms
KN026KN026

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
KN026ExperimentalPatient 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.
  • KN026

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of patients experiencing dose limiting toxicities
Time Frame:From screening to up to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax) of KN026
Time Frame:Throughout the duration of the study; up to 84 days
Safety Issue:
Description:
Measure:Time of Maximum observed serum concentration (Tmax) of KN026
Time Frame:Throughout the duration of the study; up to 84 days
Safety Issue:
Description:
Measure:Frequency and titer of anti-KN026 antibody
Time Frame:Throughout the duration of the study; up to 2 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Progression free survival according to RECIST 1.1 criteria
Time Frame:Throughout the duration of the study; up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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