KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

Study Overview
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Brief Summary
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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
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The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.

Official Title
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Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer

Conditions
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Gastric/Gastroesophageal Junction Cancer

Intervention / Treatment
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* Drug: KN026 10 mg/kg QW
* Drug: KN026 20 mg/kg Q2W
* Drug: KN026 30 mg/kg Q3W


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2 overexpression<br>HER2 IHC 3+ or IHC2+ and ISH+ | Drug: KN026 10 mg/kg QW<br>* 10 mg/kg QW as safety run-in dosage<br>Drug: KN026 20 mg/kg Q2W<br>* 20 mg/kg Q2W as target dosage<br>Drug: KN026 30 mg/kg Q3W<br>* 30 mg/kg Q3W as another target dosage<br>|
| Experimental: HER2 expression<br>HER2 IHC 2+ISH- or IHC 1+ and ISH+ | Drug: KN026 10 mg/kg QW<br>* 10 mg/kg QW as safety run-in dosage<br>Drug: KN026 20 mg/kg Q2W<br>* 20 mg/kg Q2W as target dosage<br>Drug: KN026 30 mg/kg Q3W<br>* 30 mg/kg Q3W as another target dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria | 1 years | 
| DOR | clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria | 1 years |