Clinical trial NCT03847168: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Gastric/Gastroesophageal Junction Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The proportion of patients experiencing dose limiting toxicities
timeFrame: From screening to up to 28 days
Secondary outcomes:
measure: Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
timeFrame: From screening to up to 196 days
measure: Maximum observed serum concentration (Cmax) of KN026
timeFrame: Throughout the duration of the study; up to 84 days
measure: Time of Maximum observed serum concentration (Tmax) of KN026
timeFrame: Throughout the duration of the study; up to 84 days
measure: Frequency and titer of anti-KN026 antibody
timeFrame: Throughout the duration of the study; up to 2 years
measure: The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria
timeFrame: Throughout the duration of the study; up to 2 years
measure: Progression free survival according to RECIST 1.1 criteria
timeFrame: Throughout the duration of the study; up to 2 years
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System Center Institute
state: South Carolina
Study officials:
References: