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This is a first-in-human (FIH), 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 5 proposed dose levels which are 5, 10, 15, 20 and 30 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. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN026 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN026 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients experiencing dose limiting toxicities. | From screening to up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest. | From screening to up to 112 days | |
| Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Hospital | Shanghai | 200000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| From screening to up to 112 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 |
| Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026. | Throughout the duration of the study; up to 84 days |
| Serum Half-life (T-HALF) of KN026. | Throughout the duration of the study; up to 84 days. |
| Serum clearance (CL) of KN026. | Throughout the duration of the study; up to 84 days |
| Volume of distribution at steady state (VSS) 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. |
| 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. |
| Progression free survival according to RECIST 1.1 criteria. | Throughout the duration of the study; up to 2 years. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |