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