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

NCT04398108 | Completed Phase 1

• 1 other identifier: ZL-MG-BC-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

HER2 Positive Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; MBC; HER2; Margetuximab

Outcome Measures

Primary Outcomes (4)

• Evaluation of pharmacokinetic parameter of margetuximab Cmax

  Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020

• Evaluation of pharmacokinetic parameter of margetuximab Tmax

  Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020

• Evaluation of pharmacokinetic parameter of margetuximab T1/2

  Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020

• Evaluation of pharmacokinetic parameter of margetuximab AUC

  Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020

Study Arms (1)

Margetuximab & Chosen Chemotherapy

EXPERIMENTAL

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.

Drug: Margetuximab Margetuximab-IV

Interventions

Margetuximab Margetuximab-IV DRUG

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

Margetuximab & Chosen Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (3)

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

Beijing, Beijing Municipality, 100071, China

Location

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zeifei Jiang

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

  PRINCIPAL INVESTIGATOR

• Min Yan

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Cuizhi Geng

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 21, 2020
• Study Start: August 25, 2020
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

CN (3)