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

Phase 2

• Conditions: Breast Cancer With Liver Metastases
• Interventions: Drug: MRG002

• Registration Number: NCT05263869
• Lead Sponsor: Shanghai Miracogen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-03
• Study Start: 2022-03-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-11-29
• Primary Completion: 2022-12
• Last Update Posted: 2022-12-02
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
2. Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
3. The score of ECOG for performance status is 0 or 1
4. Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
5. Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
6. Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
7. Organ functions must meet the basic requirements.
8. 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.

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Exclusion Criteria

1. Previous history of other primary malignancies;
2. Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
3. 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;
4. Central nervous system metastasis and/or neoplastic meningitis;
5. History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
6. 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;
7. Any serious or uncontrolled systemic disease judged by the investigator;
8. Uncontrolled cardiac disease;
9. Evidence of active infection;
10. Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;
11. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;
12. 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;
13. History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
14. Uncontrolled tumor-related bone pain or urgent spinal cord compression;
15. Other conditions inappropriate for participation in this study, as deemed by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by Independent Review Committee (IRC)	Baseline to study completion (up to 12 months）	ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Baseline to study completion (up to 12 months)	DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
Objective Response Rate (ORR) by Investigator	Baseline to study completion (up to 12 months)	ORR is defined as the proportion of subjects with CR and PR assessed by investigator according to RECIST v1.1.
Clinical Benefit Rate (CBR)	Baseline to study completion (up to 12 months)	CBR is defined as the proportion of subjects with CR, PR and stable disease (SD) ≥ 6 months after treatment.
Time to Response (TTR)	Baseline to study completion (up to 12 months)	TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.
Overall Survival (OS)	Baseline to study completion (up to 12 months)	OS is defined as the duration from the start of treatment to death of any cause.
PK parameters: concentration-time curve	Baseline to 14 days after decision to discontinue treatment	Plot of drug concentration changing with time after drug administration.
Disease Control Rate (DCR)	Baseline to study completion (up to 12 months)	DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Progression Free Survival (PFS)	Baseline to study completion (up to 12 months)	PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Immunogenicity (ADA)	Baseline to 14 days after decision to discontinue treatment	The proportion of patients with positive ADA results.
Adverse Events (AEs)	Baseline to 30 days after the last dose of study treatment	Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

Trial Locations

Locations (2)

Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China