Breast Cancer With Liver MetastasesPhase 2NCT05263869
A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients
A Phase 2 study testing MRG002 in people with Breast Cancer With Liver Metastases, run by Shanghai Miracogen Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer With Liver Metastases
- What is being tested?
- MRG002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesChina
- Study dates
- 23 Mar 2022to Oct 2023
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Zefei Jiang, Doctor, 13901372170, jiangzefei@csco.cog.cn
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510300
Qiang Liu, Doctor, 18922182851, liuqiang_ng_sysu@163.com
About this study
Official title: An Open-label, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Advanced HER-2 Positive Breast Cancer Patients Previously Treated With Trastuzumab and TKIs (Magic-009)
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
- Being tested
- MRG002
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG002Drug
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion (up to 12 months）
Secondary outcomes (10)
Objective Response Rate (ORR) by Investigator
ORR is defined as the proportion of subjects with CR and PR assessed by investigator according to RECIST v1.1.
Measured: Baseline to study completion (up to 12 months)
Duration of Response (DOR)
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.
Measured: Baseline to study completion (up to 12 months)
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects with CR, PR and stable disease (SD) ≥ 6 months after treatment.
Measured: Baseline to study completion (up to 12 months)
Time to Response (TTR)
TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.
Measured: Baseline to study completion (up to 12 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 12 months)
Progression Free Survival (PFS)
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 12 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 12 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
PK parameters: concentration-time curve
Plot of drug concentration changing with time after drug administration.
Measured: Baseline to 14 days after decision to discontinue treatment
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Measured: Baseline to 14 days after decision to discontinue treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start23 Mar 2022
- Primary completionDec 2022 (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 Breast Cancer With Liver MetastasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Miracogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, MD, Principal investigator, Fifth Medical Center of PLA General HospitalQiang Liu, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263869
- Sponsor's protocol ID
- MRG002-009
- Status last verified
- May 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Dec 2022
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Advanced HER-2 Positive Breast Cancer Patients Previously Treated With Trastuzumab and TKIs (Magic-009)
- ClinicalTrials.gov ID
- NCT05263869
- Acronym / sponsor ID
- MRG002-009
- Conditions
- Breast Cancer With Liver Metastases
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Shanghai Miracogen Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 3 Mar 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
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 |
Primary outcome
Objective Response Rate (ORR) by Independent Review Committee (IRC)
Time frame: 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.
10 secondary outcomes
Objective Response Rate (ORR) by Investigator
Time frame: Baseline to study completion (up to 12 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (up to 12 months)
Clinical Benefit Rate (CBR)
Time frame: Baseline to study completion (up to 12 months)
Time to Response (TTR)
Time frame: Baseline to study completion (up to 12 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 12 months)
Progression Free Survival (PFS)
Time frame: Baseline to study completion (up to 12 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 12 months)
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
PK parameters: concentration-time curve
Time frame: Baseline to 14 days after decision to discontinue treatment
Immunogenicity (ADA)
Time frame: Baseline to 14 days after decision to discontinue treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer With Liver Metastases
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
RecruitingPhase 1/2
SL-28 for Advanced Solid Tumours
Head & Neck Cancer, Pancreas Carcinoma
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, MD principal investigator
Fifth Medical Center of PLA General Hospital
Qiang Liu, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG002 in people with Breast Cancer With Liver Metastases, run by Shanghai Miracogen Inc. at 2 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 15 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
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?
Objective Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Baseline to study completion (up to 12 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 2 Dec 2022.