KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

• ClinicalTrials.gov Identifier: NCT03847168
• Recruitment Status: Recruiting
• First Posted: February 20, 2019
• Last Update Posted: July 13, 2020
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Information provided by (Responsible Party): Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Gastric/Gastroesophageal Junction Cancer	Drug: KN026	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors
• Actual Study Start Date: June 18, 2019
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. The proportion of patients experiencing dose limiting toxicities [ Time Frame: From screening to up to 28 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, South Carolina

Greenville Health System Center Institute; Recruiting

Greenville, South Carolina, United States, 29605

Contact: William Edenfield, MD 864-455-8997 jedenfield@ghs.org

Principal Investigator: William Edenfield, MD

Sponsors and Collaborators

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

More Information

• Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• ClinicalTrials.gov Identifier: NCT03847168
• Other Study ID Numbers: KN026-US-I-001
• First Posted: February 20, 2019
• Last Update Posted: July 13, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases