KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03847168 |
Recruitment Status :
Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : November 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Gastric/Gastroesophageal Junction Cancer | Drug: KN026 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 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, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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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.
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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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847168
United States, South Carolina | |
Greenville Health System Center Institute | |
Greenville, South Carolina, United States, 29605 |
Responsible Party: | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
ClinicalTrials.gov Identifier: | NCT03847168 |
Other Study ID Numbers: |
KN026-US-I-001 |
First Posted: | February 20, 2019 Key Record Dates |
Last Update Posted: | November 17, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |