KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer
Phase 2
Completed
- Conditions
- Gastric/Gastroesophageal Junction Cancer
- Interventions
- Drug: KN026 10 mg/kg QWDrug: KN026 20 mg/kg Q2WDrug: KN026 30 mg/kg Q3W
- Registration Number
- NCT03925974
- Lead Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HER2 expression KN026 30 mg/kg Q3W HER2 IHC 2+ISH- or IHC 1+ and ISH+ HER2 overexpression KN026 10 mg/kg QW HER2 IHC 3+ or IHC2+ and ISH+ HER2 overexpression KN026 20 mg/kg Q2W HER2 IHC 3+ or IHC2+ and ISH+ HER2 overexpression KN026 30 mg/kg Q3W HER2 IHC 3+ or IHC2+ and ISH+ HER2 expression KN026 10 mg/kg QW HER2 IHC 2+ISH- or IHC 1+ and ISH+ HER2 expression KN026 20 mg/kg Q2W HER2 IHC 2+ISH- or IHC 1+ and ISH+
- Primary Outcome Measures
Name Time Method ORR 1 years clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
DOR 1 years clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
307 Hospital of PLA
🇨🇳Beijing, Beijing, China