KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03847168
• Other study ID #: KN026-US-I-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Gastric/Gastroesophageal Junction Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Greenville Health System Center Institute	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients experiencing dose limiting toxicities		From screening to up to 28 days
Secondary	Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest		From screening to up to 196 days
Secondary	Maximum observed serum concentration (Cmax) of KN026		Throughout the duration of the study; up to 84 days
Secondary	Time of Maximum observed serum concentration (Tmax) of KN026		Throughout the duration of the study; up to 84 days
Secondary	Frequency and titer of anti-KN026 antibody		Throughout the duration of the study; up to 2 years
Secondary	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
Secondary	Progression free survival according to RECIST 1.1 criteria		Throughout the duration of the study; up to 2 years