A Phase 1 interventional study of KN026 in Breast Cancer and Gastric/Gastroesophageal Junction Cancer, sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Phase 1, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 22 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jiangsu Alphamab Biopharmaceuticals Co., Ltd is the lead sponsor of 38 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
The proportion of patients experiencing dose limiting toxicities
Time frame: From screening to up to 28 days
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
Maximum observed serum concentration (Cmax) of KN026
Time frame: Throughout the duration of the study; up to 84 days
Time of Maximum observed serum concentration (Tmax) of KN026
Time frame: Throughout the duration of the study; up to 84 days
Frequency and titer of anti-KN026 antibody
Time frame: Throughout the duration of the study; up to 2 years
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
Progression free survival according to RECIST 1.1 criteria
Time frame: Throughout the duration of the study; up to 2 years
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd