Spots Global Cancer Trial Database for A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC

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Trial Identification

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

Official Title: An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies

Study ID: NCT04398108

Conditions

HER2 Positive Metastatic Breast Cancer

Interventions

Margetuximab Margetuximab-IV

Study Description

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 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.

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 Chinese patients. Subjects should have received treatment with at least one, and no more than four lines of therapy overall in the metastatic setting. Eligible subjects will receive margetuximab plus chemotherapy. The dosage and administering of margetuximab is 15 mg/kg IV Q3W. Investigators selected one of three backbone chemotherapy regimens given at standard doses: capecitabine, vinorelbine or gemcitabine. Subject will receive the treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anti-tumor treatment therapy, or death (whichever occurs first).