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

NCT ID: NCT04398108

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2021-04-27

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).

Conditions

HER2 Positive Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Margetuximab & Chosen Chemotherapy

The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions.

Group Type: EXPERIMENTAL

Margetuximab Margetuximab-IV

Intervention Type: DRUG

Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV

Interventions

Margetuximab Margetuximab-IV

Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeifei Jiang

Role: PRINCIPAL_INVESTIGATOR

The fifth medical center of the General Hospital of people's Liberation Army of China

Min Yan

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Cuizhi Geng

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

The fifth medical center of the General Hospital of people's Liberation Army of China

Beijing, Beijing Municipality, China

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

ZL-MG-BC-001

Identifier Type: -

Identifier Source: org_study_id