Description:
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.
Title
- Brief Title: KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
- 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 IDs
- ORG STUDY ID:
KN026-US-I-001
- NCT ID:
NCT03847168
Conditions
- Breast Cancer
- Gastric/Gastroesophageal Junction Cancer
Interventions
Drug | Synonyms | Arms |
---|
KN026 | | KN026 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
KN026 | Experimental | 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. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The proportion of patients experiencing dose limiting toxicities |
Time Frame: | From screening to up to 28 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Maximum observed serum concentration (Cmax) of KN026 |
Time Frame: | Throughout the duration of the study; up to 84 days |
Safety Issue: | |
Description: | |
Measure: | Time of Maximum observed serum concentration (Tmax) of KN026 |
Time Frame: | Throughout the duration of the study; up to 84 days |
Safety Issue: | |
Description: | |
Measure: | Frequency and titer of anti-KN026 antibody |
Time Frame: | Throughout the duration of the study; up to 2 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Progression free survival according to RECIST 1.1 criteria |
Time Frame: | Throughout the duration of the study; up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
Last Updated
July 13, 2020