A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

NCT04924699 | Unknown Phase 2

• 1 other identifier: MRG002-004
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary objective of Phase III is to evaluate the efficacy and safety of MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have been previously treated with trastuzumab (or a biosimilar) and an anti-HER2 tyrosine kinase inhibitor (anti-HER2-TKI) and have progressed on or after the most recent therapy.

Conditions

Advanced Breast Cancer; Metastatic Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by Independent Review Committee (IRC)

  PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause assessed by Independent Review Committee (IRC) according to RECIST v1.1.

  Baseline to study completion（up to 36 months）

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Baseline to study completion (up to 36 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 36 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 36 months)

• PFS by investigator

  Baseline to study completion (up to 36 months)

• Overall Survival (OS)

  Baseline to study completion (up to 36 months)

Study Arms (2)

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

Trastuzumab Emtansine for Injection

ACTIVE COMPARATOR

Trastuzumab Emtansine for Injection will be administrated via intravenous infusion of 3.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Drug: Trastuzumab Emtansine for Injection

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Trastuzumab Emtansine for Injection DRUG

Administrated intravenously

Trastuzumab Emtansine for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18 to 75 (including 18 and 75)，both genders;
• \. Expected survival time ≥ 6 months;
• \. The score of ECOG for performance status is 0 or 1;
• \. Patients with histologically and/or cytologically confirmed HER2-positive invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC);
• \. Phase II: patients with advanced or metastatic disease who have previously failed trastuzumab (containing trastuzumab biosimilar) ± pertuzumab and taxane, or progressed within 12 months after neoadjuvant or adjuvant therapy (using trastuzumab (containing trastuzumab biosimilar) ± pertuzumab and taxane regimen); patients who have failed TKI and/or HER2-targeted ADCs can also be included. Phase III: patients who have received 1 or 2 prior lines of anti-HER2 therapy for locally advanced or recurrent/metastatic breast cancer (in the case of (neo) adjuvant therapy, such (neo) adjuvant therapy also counts as one line of anti-HER2 therapy if relapse occurs within 12 months of (neo) adjuvant therapy); have received prior treatment with trastuzumab (containing a trastuzumab biosimilar) and anti-HER2-TKI; have not received prior treatment with ADCs;
• \. Patients must have imaging evidence of tumor progression during or after the most recent treatment confirmed by the investigator and have at least one measurable lesion baseline according to RECIST 1.1;
• \. Organ functions must meet the basic requirements;
• \. Reproductive male and female patients of childbearing age shall be willing to take effective contraceptive measures from the date of signing the ICF to 6 months after the last dose. Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose.

You may not qualify if:

• \. History of other primary malignancies;
• \. Received investigational drugs from other clinical trials, any anti-tumor drugs, or radiotherapy within 4 weeks prior to the first dose/randomization; or use of endocrine therapy for breast cancer within 7 days prior to the first dose/randomization, or have current requirement of endocrine therapy; or have received strong CYP3A4 inhibitors or inducers within 2 weeks prior to the first dose/randomization, or have current requirement of CYP3A4 inhibitors or inducers; cumulative doxorubicin up to 450 mg/m2 or equivalent prior to the first dose/randomization; or had major surgery within 4 weeks prior to the first dose/randomization without full recovery or planned surgery within 12 weeks after study treatment;
• \. Presence of central nervous system (CNS) metastasis;
• \. The pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of the subjects or urgently needs clinical treatment. Or the pericardial effusion with combined clinical symptoms;
• \. Any severe or uncontrolled systemic disease, uncontrolled heart disease, uncontrolled diabetes, and active bleeding signs judged by the investigator;
• \. Evidence of active infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection, active bacteria infection requiring systematic anti-infective therapy, 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;
• \. 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/randomization;
• \. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc;
• \. Other conditions inappropriate for participation in this study, as deemed by the investigator;
• \. Presence of peripheral neuropathy \> Grade 1;
• \. History of cirrhosis (decompensated cirrhosis Child-Pugh class B, C).

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (19)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

ACTIVE NOT RECRUITING

Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

ACTIVE NOT RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

ACTIVE NOT RECRUITING

The Fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, 050035, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

ACTIVE NOT RECRUITING

The First Affiliated Hosipital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

ACTIVE NOT RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

ACTIVE NOT RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

ACTIVE NOT RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

ACTIVE NOT RECRUITING

Liaoning Cancer Hospital & Institute

Shengyang, Liaoning, 110801, China

ACTIVE NOT RECRUITING

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

ACTIVE NOT RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjing, Tianjing, 300060, China

ACTIVE NOT RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

ACTIVE NOT RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zefei Jiang, Doctor

  Fifth Medical Center of PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Yunjinang Liu, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: June 30, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (19)