A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients

NCT05263869 | Unknown Phase 2

• 1 other identifier: MRG002-009
• Study Type: interventional
• Target: 99
• 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 positive breast cancer with liver metastases.

Conditions

Breast Cancer With Liver Metastases

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2

Outcome Measures

Primary Outcomes (1)

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

  ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.

  Baseline to study completion (up to 12 months）

Secondary Outcomes (10)

• Objective Response Rate (ORR) by Investigator

  Baseline to study completion (up to 12 months)

• Duration of Response (DOR)

  Baseline to study completion (up to 12 months)

• Clinical Benefit Rate (CBR)

  Baseline to study completion (up to 12 months)

• Time to Response (TTR)

  Baseline to study completion (up to 12 months)

• Disease Control Rate (DCR)

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

You may qualify if:

• Willing to sign the informed consent form and follow the requirements specified in the protocol.
• Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
• The score of ECOG for performance status is 0 or 1
• Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
• Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
• Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
• Organ functions must meet the basic requirements.
• Patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug.

You may not qualify if:

• Previous history of other primary malignancies;
• Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
• Previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, CYP3A4 inhibitors or inducers, anthracyclines and other treatments;
• Central nervous system metastasis and/or neoplastic meningitis;
• History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
• Pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; Or pericardial effusion with combined clinical symptoms;
• Any serious or uncontrolled systemic disease judged by the investigator;
• Uncontrolled cardiac disease;
• Evidence of active infection;
• Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;
• History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;
• Patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment;
• History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
• Uncontrolled tumor-related bone pain or urgent spinal cord compression;
• Other conditions inappropriate for participation in this study, as deemed by the investigator.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (2)

Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510300, China

RECRUITING

Study Officials

• Zefei Jiang, MD

  Fifth Medical Center of PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Qiang Liu, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  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 21, 2022
• First Posted: March 3, 2022
• Study Start: March 23, 2022
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)