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Non-small- Cell Lung Cancer (NSCLC)Phase 2NCT05141786

A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

A Phase 2 study testing MRG002 in people with Non-small- Cell Lung Cancer (NSCLC), run by Shanghai Miracogen Inc. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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-mutated unresectable or metastatic non-small-cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small- Cell Lung Cancer (NSCLC)
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
100 participants
Where
1 siteChina
Study dates
Dec 2021to Dec 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

  • Understands and provides written informed consent and willing to follow the requirements specified in protocol.
  • Aged 18 to 75 (including 18 and 75), both genders;
  • Life expectancy ≥ 3 months;
  • Advanced NSCLC patients with HER2 mutation in tumor tissue/blood confirmed by NGS/PCR methods. If no prior test results, a tumor tissue specimen from the most recent archival or biopsy (if archival tissue is not available or sufficient) should be provided.
  • Histologically and/or cytologically confirmed unresectable locally advanced or NSCLC with histological subtype of either non-squamous cell carcinoma or squamous cell carcinoma, and patients have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have failed at least one prior line of Stand of Care (SOC) therapy. Those who refuse or cannot tolerate chemotherapy can also be enrolled.
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  • The score of ECOG for performance status is 0 or 1 with no deterioration within 2 weeks prior to the first dose of the study drug.
  • Radiographic evidence of tumor progression during or after the most recent therapy confirmed by investigator.
  • Organ functions must meet the basic requirements.
  • A negative serum or urine pregnancy test within 72 hours of receiving the first dose of study treatment. A serum pregnancy test is required if the urine pregnancy test is positive or cannot be confirmed negative. Women who are pregnant or breast feeding should be excluded.
  • Adequate contraception for women of childbearing potential is defined as hormonal birth control or an intrauterine device and willingness to use 2 methods of contraception or be surgically sterile, or abstain from hetero sexual activity for the course of the study through 120 days after receiving the last dose of study medications.
  • Male patients must be willing to use a latex condom during any sexual contact with females of childbearing potential during and for 120 days after the last infusion of MRG002, even after having undergone a successful vasectomy.

Who cannot join

  • Prior treatment with HER2-targeted ADC or HER2 targeted antibody.
  • Histologically/cytologically confirmed small-cell lung cancer (SCLC) and mixed type of lung cancer with SCLC histopathology.
  • Received systemic cytotoxic chemotherapy, small molecule targeted drugs within 3 weeks before the first dose of the study drug; received anti-tumor biological therapy, immunotherapy or major surgery within 4 weeks before first dose of the study drug. Use of any other type of anti-cancer therapy is prohibited throughout the study.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Presence of severe cardiac dysfunction within 6 months of enrollment.
  • Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.
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  • Known history of malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Uncontrolled or poorly controlled hypertension. Patients with active bleeding, history of coagulation disorder, or on Coumarin anticoagulant.
  • Known allergic reactions to any component or excipient of MRG002, or known allergic reaction to other prior anti-HER2 (including investigational) or to other monoclonal antibodies ≥ Grade 3.
  • Known active infection, including hepatitis B, hepatitis C. Presence of other significant liver disease.
  • Concurrent, serious, uncontrolled infection or known infection with human immunodeficiency virus (HIV), or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune diseases; or previously undergone allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or has previously received a solid organ transplantation.
  • Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection and has not received systemic antibiotics within 14 days unless treated and resolved prior to study treatment.
  • Received a live-viral vaccination within 30 days prior to the first dose of the study drug. Seasonal influenza or approved COVID-19 vaccines that do not contain live virus are allowed.
  • History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, current need for continuous oxygen therapy, or any history of interstitial lung disease or pneumonia that required oral or intravenous glucocorticoids to assist with management.
  • Patients who are receiving immunologically based therapy for any reason.
  • History or current active or chronic autoimmune disease, or glomerulonephritis that has required systemic therapy in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
  • Has a clinically significant cardiac condition.
  • Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites requiring ≥ 1 drainage per month.
  • Use of strong CYP3A4 inhibitors or inducers with MRG002 is prohibited due to increased risk of adverse reactions or potential adverse reduction in potential efficacy.
  • Any other disease or clinically significant abnormality in laboratory parameters, or serious medical or psychiatric illnesses/conditions, substance abuse disorder including alcoholism, which in the judgment of the Investigator might compromise the safety of the patient, integrity of the study, interfere with the patient participation in the study, or confound or compromise the study objectives and their interpretability.

Trial locations and contacts

1 site in 1 country.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Shun Lu, MD, 13601813062, shun_lu@hotmail.com

Other trials in China

About this study

Official title: An Open-label, Multi-center, Non-randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-mutated unresectable or metastatic non-small-cell lung cancer (NSCLC).

Read the detailed description

The trial consists of two stages: efficacy exploration and efficacy verification.

At the first stage, at most 30 patients will be enrolled for each of the two cohorts as defined by HER2 mutation sites. If ≥8 patients achieved objective response, the second stage will be continued; otherwise the trial will be terminated. Approximately 40 patients will be enrolled in the second stage.

Being tested
MRG002
Keywords
MRG002, Antibody Drug Conjugate (ADC), HER2, Non-small-cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

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 NCT05141786
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 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 (8)

  1. 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)

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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 45 days after the last dose of study treatment.

  7. PK parameters: 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.

  8. Immunogenicity (ADA)

    The proportion of patients with positive ADA 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.

  1. First posted2 Dec 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141786
Sponsor's protocol ID
MRG002-008
Status last verified
Nov 2021
First submitted
19 Nov 2021
Last updated
2 Dec 2021
Results posted
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 Non-small- Cell Lung Cancer (NSCLC), run by Shanghai Miracogen Inc. at 1 site 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 12 inclusion and 20 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 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

On the ClinicalTrials.gov record for NCT05141786.

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 2021.

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