KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric/Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: KN026 10 mg/kg QW; Drug: KN026 20 mg/kg Q2W; Drug: KN026 30 mg/kg Q3W

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: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • 307 Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KN026-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No