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Advanced or Metastatic Breast CancerPhase 2NCT04742153

A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

A Phase 2 study testing MRG002 in people with Advanced or Metastatic Breast Cancer, run by Shanghai Miracogen Inc. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic Breast Cancer
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
66 participants
Where
2 sitesChina
Study dates
13 May 2021to Feb 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary to sign the ICF and follow the requirements specified in the protocol;
  • Aged ≥ 18, both genders;
  • Expected survival time ≥ 12 weeks;
  • The score of ECOG for performance status is 0 or 1;
  • Subjects with histologically confirmed HER2-low breast cancer, are currently in the locally advanced or metastatic stage, and are ineligible for radical excision, and have received at least first-line standard treatment for recurrent or metastatic breast cancer;
  • Archival or biopsy tumor specimens should be provided;
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  • Subjects must have imaging evidence of tumor progression during or after the most recent treatment confirmed by the investigator and at least one measurable lesion at the baseline according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1);
  • Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities);
  • No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
  • The level of organ functions must meet the basic requirements;
  • Reproductive male subjects and female subjects of childbearing age shall be willing to take effective contraceptive measures from the date signing the ICF to 6 months after the last dose of the IP.

Who cannot join

  • With previous history of other primary malignancies;
  • Received chemotherapy, radiotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose;
  • The subjects have central nervous system (CNS) metastasis;
  • Subjects with clinical symptoms of pleural effusion, seroperitoneum or pericardial effusion, for which treatment by puncture and drainage is required;
  • Subjects with peripheral neuropathy of greater than Grade 2 (NCI CTCAE v5.0);
  • Any severe or uncontrolled systemic disease;
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  • Patients with poorly controlled heart disease;
  • Evidence of active infection, including but not limited to hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection, uncontrolled active bacterial infection, 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;
  • Disease progression or recurrence occurred during or after the previous treatment, without evidence of CT/MRI examination results;
  • Subjects with uncontrolled concurrent diseases may have limited ability to obey the study requirements or impaired ability to sign the written ICF;
  • 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;
  • Received anti-tumor vaccine treatment 4 weeks prior to the first dose, or plan to participate in anti-tumor vaccine studies;
  • History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc;
  • Pulmonary embolism or deep vein thrombosis occurred within 3 months prior to the first dose;
  • Female subjects with positive result in serum pregnancy test, or female subjects within lactation period and do not agree to take adequate contraceptive measures during the trial and 6 months after receiving the IP;
  • Other conditions inappropriate for participation in this study, as deemed by the investigator.

Trial locations and contacts

2 sites in 1 country.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

China2 sites, 2 recruiting

  • Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

    Zefei Jiang, Doctor, 86-010-66947797, jiangzefei@csco.org.cn

    Recruiting

  • The Fourth hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035

    Cuizhi Geng, Doctor, 86-0311-66696311, gengcuizhi@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Non-randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

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

Read the detailed description

The study will be conducted in two parts. The first part is efficacy exploration and the second part is efficacy verification. During the course of efficacy exploration, 33 subjects will be enrolled to preliminarily evaluate the safety and efficacy of MRG002. The second part will be adjusted according to the result of the first part. 29 subjects are planned to be enrolled. Considering the dropout rate of 10%, approximately 33 subjects are planned to be enrolled. A total of 66 subjects are planned to be enrolled in efficacy exploration and verification.

Being tested
MRG002
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

Study groups in NCT04742153
Study groupRoleWhat they receive
MRG002ExperimentalMRG002 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.

  1. Objective Response Rate (ORR) by Independent Review Committee(IRC)

    ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

    Measured: Baseline to study completion (12 months)

Secondary outcomes (10)

  1. Objective Response Rate (ORR) by Investigator

    ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

    Measured: Baseline to study completion (12 months)

  2. Progression Free Survival (PFS)

    PFS was 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 (12 months)

  3. 6-month and 12-month Progression Free Survival Rate (PFSR)

    The proportions of subjects surviving without progression from the start of treatment to 6-month and 12-month duration.

    Measured: Baseline to study completion (12 months)

  4. Time to Response (TTR)

    TTR was defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

    Measured: Baseline to study completion (12 months)

  5. Duration of Response (DoR)

    DOR was 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 (12 months)

  6. Disease Control Rate (DCR)

    DCR was defined as the proportions of subjects achieving CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion (12 months)

  7. Overall Survival (OS)

    OS was defined as the duration from the start of treatment to death of any cause.

    Measured: Baseline to study completion (12 months)

  8. Incidence of Adverse Events (AEs)

    Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0.

    Measured: Baseline to 30 days after the last dose of study treatment

  9. Pharmacokinetics (PK) parameter for MRG002: concentration-time curve

    Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).

    Measured: Baseline to 14 days after decision to discontinue treatment

  10. Immunogenicity

    The incidence of anti-drug antibody (ADA) analysis will be summarized for all patients who received at least one cycle study treatment.

    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.

  1. First posted5 Feb 2021
  2. Study start13 May 2021
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742153
Sponsor's protocol ID
MRG002-005
Status last verified
Sep 2022
First submitted
4 Feb 2021
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG002 in people with Advanced or Metastatic Breast Cancer, 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 11 inclusion and 17 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 7 Sep 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 (12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742153.

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 7 Sep 2022.

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