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

Sponsor

Shanghai Miracogen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04924699

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

3.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Breast Cancer Metastatic Breast Cancer	Drug: MRG002	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRG002 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 Administrated intravenously

Arm

Intervention/Treatment

Experimental: MRG002

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

Administrated intravenously

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) by Independent Review Committee (IRC) [Baseline to study completion (up to12 months)]
ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by Independent Review Committee (IRC) according to RECIST v1.1.

Secondary Outcome Measures

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.
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.
Time to Response (TTR) [Baseline to study completion (up to 12 months)]
TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.
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.
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.
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.
Concentration-time curve [Baseline to 30 days after the last dose of study treatment]
Plot of drug concentration changing with time after drug administration.
Immunogenicity [Baseline to 30 days after the last dose of study treatment.]
The proportion of patients with positive ADA immunogenicity results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 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);
Failed in the prior trastuzumab ± pertuzumab and taxane therapy with advanced/metastatic disease, or progression within 12 months after new adjuvant or adjuvant therapy; or those who have failed in the prior TKI and/or HER2-ADC therapy can also be enrolled;
Patients must have imaging evidence of tumor progression during or after the most recent treatment confirmed by the investigator and at least one measurable lesion baseline according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1);
Organ functions must meet the basic requirements;
Willing to sign the ICF and follow the requirements specified in the protocol; Reproductive male and female subjects 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.

Exclusion Criteria:

1. History of other primary malignancies;

Received other study drugs for clinical trials, any anti-tumor drugs/ biological or investigational therapeutic drug, radiotherapy, anti-tumor vaccine therapy, etc., within 4 weeks prior to the first dose;
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;
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China	230001
2	Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100071
3	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
4	Chongqing Cancer Hospital	Chongqing	Chongqing	China	400030
5	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080
6	The Fourth hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050035
7	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
8	The First Affiliated Hosipital of Zhengzhou University	Zhengzhou	Henan	China	450052
9	Hunan Cancer Hospital	Changsha	Hunan	China	410013
10	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
11	Xuzhou Central Hospital	Xuzhou	Jiangsu	China	221009
12	Jilin Cancer Hospital	Changchun	Jilin	China	130012
13	Liaoning Cancer Hospital & Institute	Shengyang	Liaoning	China	110801
14	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong	China	250013
15	Shanghai East Hospital	Shanghai	Shanghai	China	200120
16	Tianjin Medical University Cancer Institute & Hospital	Tianjing	Tianjing	China	300060
17	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310005
18	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
19	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310020

Sponsors and Collaborators

Shanghai Miracogen Inc.

Investigators

Principal Investigator: Zefei Jiang, Doctor, Fifth Medical Center of PLA General Hospital
Principal Investigator: Yunjinang Liu, Doctor, The Fourth Hospital of Hebei Medical University