Advanced Breast CancerPhase 2/3NCT04924699
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
A Phase 2/3 study testing MRG002 and Trastuzumab Emtansine for Injection in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Shanghai Miracogen Inc. at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- MRG002 and Trastuzumab Emtansine for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 19 sitesChina
- Study dates
- 30 Jun 2021to Oct 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18 to 75 (including 18 and 75)，both genders;
- 2. Expected survival time ≥ 6 months;
- 3. The score of ECOG for performance status is 0 or 1;
- 4. Patients with histologically and/or cytologically confirmed HER2-positive invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC);
- 5. 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;
- 6. 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;
- 7. Organ functions must meet the basic requirements;
- 8. 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.
Who cannot join
- 1. History of other primary malignancies;
- 2. 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;
- 3. Presence of central nervous system (CNS) metastasis;
- 4. 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;
- 5. Any severe or uncontrolled systemic disease, uncontrolled heart disease, uncontrolled diabetes, and active bleeding signs judged by the investigator;
- 6. 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;
Show all 12Show fewer
- 7. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
- 8. 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;
- 9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc;
- 10. Other conditions inappropriate for participation in this study, as deemed by the investigator;
- 11. Presence of peripheral neuropathy > Grade 1;
- 12. History of cirrhosis (decompensated cirrhosis Child-Pugh class B, C).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 6 recruiting
- Recruiting
Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Zefei Jiang, Doctor, 13901372170, jiangzefei@csco.cog.cn
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hongyan Ying, (86-10)-69156699, yinghy15@163.com
- Active, not recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
- Active, not recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Active, not recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Active, not recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
- Active, not recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
- Active, not recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
- Not yet recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020
Xian Wang, 0571-8609 0073, wangxian@srrsh.com
- Active, not recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
- Active, not recruiting
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 250013
- Active, not recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Qun Li, 021-38804518, liqun@fudan.edu.cn
- Active, not recruiting
Liaoning Cancer Hospital & Institute
Shengyang, Liaoning, 110801
- Not yet recruiting
The Fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035
Yunjiang Liu, Doctor, 13703297890, Lyj818326@126.com
- Active, not recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, 300060
- Active, not recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
- Active, not recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
- Not yet recruiting
The First Affiliated Hosipital of Zhengzhou University
Zhengzhou, Henan, 450052
Yuanting Gu, 0371-66913114, guyuanting2009@163.com
About this study
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
- Being tested
- MRG002, Trastuzumab Emtansine for Injection
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Breast Cancer (BC)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG002Drug
Administrated intravenously
Trastuzumab Emtansine for InjectionDrug
Administrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Trastuzumab Emtansine for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion（up to 36 months）
Secondary outcomes (8)
Objective Response Rate (ORR)
ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Baseline to study completion (up to 36 months)
Duration of Response (DoR)
DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.
Measured: Baseline to study completion (up to 36 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 36 months)
PFS by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 36 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 36 months)
Adverse Events (AEs)
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.
Measured: Baseline to 30 days after the last dose of study treatment
Concentration-time curve
Plot of drug concentration changing with time after drug administration.
Measured: Baseline to 30 days after the last dose of study treatment
Immunogenicity
The proportion of patients with positive ADA immunogenicity results.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start30 Jun 2021
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Miracogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, Doctor, Principal investigator, Fifth Medical Center of PLA General HospitalYunjinang Liu, Doctor, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924699
- Sponsor's protocol ID
- MRG002-004
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04924699
- Acronym / sponsor ID
- MRG002-004
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Breast Cancer (BC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shanghai Miracogen Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG002 | Experimental | Drug: MRG002MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle). |
| Trastuzumab Emtansine for Injection | Active comparator | Drug: Trastuzumab Emtansine for InjectionTrastuzumab 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Aged 18 to 75 (including 18 and 75)，both genders;
- 2. Expected survival time ≥ 6 months;
- 3. The score of ECOG for performance status is 0 or 1;
- 4. Patients with histologically and/or cytologically confirmed HER2-positive invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC);
- 5. 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;
Key exclusion criteria (12 listed)
- 1. History of other primary malignancies;
- 2. 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;
- 3. Presence of central nervous system (CNS) metastasis;
- 4. 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;
- 5. Any severe or uncontrolled systemic disease, uncontrolled heart disease, uncontrolled diabetes, and active bleeding signs judged by the investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG002Administrated intravenously | Drug | MRG002 |
| Trastuzumab Emtansine for InjectionAdministrated intravenously | Drug | Trastuzumab Emtansine for Injection |
Primary outcome
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Time frame: Baseline to study completion（up to 36 months）
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.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to study completion (up to 36 months)
Duration of Response (DoR)
Time frame: Baseline to study completion (up to 36 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 36 months)
PFS by investigator
Time frame: Baseline to study completion (up to 36 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 36 months)
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Concentration-time curve
Time frame: Baseline to 30 days after the last dose of study treatment
Immunogenicity
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zefei Jiang, Doctor principal investigator
Fifth Medical Center of PLA General Hospital
Yunjinang Liu, Doctor principal investigator
Hebei Medical University Fourth Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MRG002 and Trastuzumab Emtansine for Injection in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Shanghai Miracogen Inc. at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) by Independent Review Committee (IRC) (time frame: Baseline to study completion（up to 36 months）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.