A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

NCT04742153 | Unknown Phase 2

• 1 other identifier: MRG002-005
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced or Metastatic Breast Cancer

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Breast Cancer (BC)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to study completion (12 months)

Secondary Outcomes (10)

• Objective Response Rate (ORR) by Investigator

  Baseline to study completion (12 months)

• Progression Free Survival (PFS)

  Baseline to study completion (12 months)

• 6-month and 12-month Progression Free Survival Rate (PFSR)

  Baseline to study completion (12 months)

• Time to Response (TTR)

  Baseline to study completion (12 months)

• Duration of Response (DoR)

  Baseline to study completion (12 months)

Study Arms (1)

MRG002

EXPERIMENTAL

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

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Eligibility Criteria

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

You may qualify if:

• 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;
• Reproductive male subjects and female subjects of childbearing age shall be willing to take effective contraceptive measures from the date signing the ICF to 6 months after the last dose of the IP.

You may not qualify if:

• 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;
• Subjects with uncontrolled concurrent diseases may have limited ability to obey the study requirements or impaired ability to sign the written ICF;
• Subjects with active autoimmune disease or a history of autoimmune disease are receiving immunosuppressive agents or systemic hormone therapy, and are still receiving within 2 weeks prior to enrollment;
• Received anti-tumor vaccine treatment 4 weeks prior to the first dose, or plan to participate in anti-tumor vaccine studies;
• History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc;
• Pulmonary embolism or deep vein thrombosis occurred within 3 months prior to the first dose;

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (2)

Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

The Fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, 050035, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Zefei Jiang, Doctor

  Fifth Medical Center of PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Cuizhi Geng, Doctor

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 5, 2021
• Study Start: May 13, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)