KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Gastric/Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: KN026

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Center Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: KN026; Patient will be intravenously administrated with one dose of KN026 every week or every other week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients experiencing dose limiting toxicities	From screening to up to 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria	Throughout the duration of the study; up to 2 years
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest	From screening to up to 196 days
Maximum observed serum concentration (Cmax) of KN026	Throughout the duration of the study; up to 84 days
Time of Maximum observed serum concentration (Tmax) of KN026	Throughout the duration of the study; up to 84 days
Frequency and titer of anti-KN026 antibody	Throughout the duration of the study; up to 2 years
Progression free survival according to RECIST 1.1 criteria	Throughout the duration of the study; up to 2 years

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KN026-US-I-001

Drug and device information, study documents

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