KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

NCT ID: NCT03847168

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2022-12-31

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.

Conditions

Breast Cancer; Gastric/Gastroesophageal Junction Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

KN026

Intervention Type: DRUG

Patient will be intravenously administrated with one dose of KN026 every week or every other week.

Interventions

KN026

Patient will be intravenously administrated with one dose of KN026 every week or every other week.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Greenville Health System Center Institute

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

KN026-US-I-001

Identifier Type: -

Identifier Source: org_study_id