A Multicenter, Non-randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

Shanghai Miracogen Inc.2 sites in 1 country66 target enrollmentMay 13, 2021

ConditionsAdvanced or Metastatic Breast Cancer

InterventionsMRG002

DrugsMRG002

Overview

Phase: Phase 2
Intervention: MRG002
Conditions: Advanced or Metastatic Breast Cancer
Sponsor: Shanghai Miracogen Inc.
Enrollment: 66
Locations: 2
Primary Endpoint: Objective Response Rate (ORR) by Independent Review Committee(IRC)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.

Detailed Description

The study will be conducted in two parts. The first part is efficacy exploration and the second part is efficacy verification. During the course of efficacy exploration, 33 subjects will be enrolled to preliminarily evaluate the safety and efficacy of MRG002. The second part will be adjusted according to the result of the first part. 29 subjects are planned to be enrolled. Considering the dropout rate of 10%, approximately 33 subjects are planned to be enrolled. A total of 66 subjects are planned to be enrolled in efficacy exploration and verification.

Registry

clinicaltrials.gov

Start Date

May 13, 2021

End Date

February 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Miracogen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary to sign the ICF and follow the requirements specified in the protocol;
•Aged ≥ 18, both genders;
•Expected survival time ≥ 12 weeks;
•The score of ECOG for performance status is 0 or 1;
•Subjects with histologically confirmed HER2-low breast cancer, are currently in the locally advanced or metastatic stage, and are ineligible for radical excision, and have received at least first-line standard treatment for recurrent or metastatic breast cancer;
•Archival or biopsy tumor specimens should be provided;
•Subjects must have imaging evidence of tumor progression during or after the most recent treatment confirmed by the investigator and at least one measurable lesion at the baseline according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1);
•Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities);
•No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
•The level of organ functions must meet the basic requirements;

Exclusion Criteria

•With previous history of other primary malignancies;
•Received chemotherapy, radiotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose;
•The subjects have central nervous system (CNS) metastasis;
•Subjects with clinical symptoms of pleural effusion, seroperitoneum or pericardial effusion, for which treatment by puncture and drainage is required;
•Subjects with peripheral neuropathy of greater than Grade 2 (NCI CTCAE v5.0);
•Any severe or uncontrolled systemic disease;
•Patients with poorly controlled heart disease;
•Evidence of active infection, including but not limited to hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection, uncontrolled active bacterial infection, infection caused by other viruses, fungi, rickettsia or parasites;
•History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
•Disease progression or recurrence occurred during or after the previous treatment, without evidence of CT/MRI examination results;

Arms & Interventions

MRG002

MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Intervention: MRG002

Outcomes

Primary Outcomes

Objective Response Rate (ORR) by Independent Review Committee(IRC)

Time Frame: Baseline to study completion (12 months)

ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

Secondary Outcomes

Progression Free Survival (PFS)(Baseline to study completion (12 months))
Pharmacokinetics (PK) parameter for MRG002: concentration-time curve(Baseline to 14 days after decision to discontinue treatment)
Overall Survival (OS)(Baseline to study completion (12 months))
Objective Response Rate (ORR) by Investigator(Baseline to study completion (12 months))
6-month and 12-month Progression Free Survival Rate (PFSR)(Baseline to study completion (12 months))
Immunogenicity(Baseline to 14 days after decision to discontinue treatment)
Time to Response (TTR)(Baseline to study completion (12 months))
Duration of Response (DoR)(Baseline to study completion (12 months))
Disease Control Rate (DCR)(Baseline to study completion (12 months))
Incidence of Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)