Overview

A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC

Status:
Completed
Trial end date:
2021-04-27
Target enrollment:
0
Participant gender:
All
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 cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab). The primary endpoint of this study is PK parameters of margetuximab.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zai Lab (Shanghai) Co., Ltd.
Treatments:
Antibodies, Monoclonal
Margetuximab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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