Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
Lead Sponsor:
Zai Lab (Shanghai) Co., Ltd.
Conditions:
HER2 Positive Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast can...
Detailed Description
Approximately 16\~20 Chinese subjects will be enrolled. Eligible subjects are HER2 positive, metastatic breast cancer who has received standard anti-HER2 directed therapy in the metastatic setting in ...
Eligibility Criteria
Inclusion
- Written informed consent obtained prior to performing any protocol-related procedures
- Male or female, age ≥ 18 years old at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject has histologically confirmed HER2 positive metastatic breast cancer.
- Have received standard anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab), regardless of having received (neo)adjuvant anti-HER2 therapy or not.
- Have received treatment with no more than four lines of therapy overall in the metastatic setting (including anti-HER2 targeted therapy or chemotherapy) and must have disease progressed on or after, the most recent line of therapy. per RECIST 1.1.
- Previous adverse events associated with anti-tumor therapy have been recovered to NCI-CTCAE v4.03 Grade ≤1 (except NCI-CTCAE v4.03 Grade ≤2 alopecia, stable sensory neuropathy, or stabilized electrolyte disturbance after fluid transfusion).
- Subject has life expectancy ≥12 weeks.
- Subject has no supportive therapy of blood transfusion or growth factor within 4 weeks before dosed and has adequate organ functions
- Subject has a negative test result of pregnancy test at screening.
Exclusion
- Subject has symptomatic, uncontrolled brain or pia mater metastasis.
- Subject has third interstitial effusion that cannot be controlled by drainage or other means.
- Subject has local or systemic anti-tumor treatment within 2 weeks prior to enrollment
- Subject has any investigational treatment within 4 weeks prior to enrollment (including margetuximab)
- Subject has history of major surgery with unrecovered surgical effect within 4 weeks prior to enrollment
- Subject has other malignant tumor (complete cured in situ cervical cancer, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma are not included) within 5 years prior to enrollment
- Subject has severe and uncontrolled disease
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04398108
Start Date
August 25 2020
End Date
April 27 2021
Last Update
June 14 2021
Active Locations (3)
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1
The fifth medical center of the General Hospital of people's Liberation Army of China
Beijing, Beijing Municipality, China, 100071
2
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000