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Locally Advanced Gastric CancerPhase 2NCT05141747

A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.

A Phase 2 study testing MRG002 in people with Locally Advanced Gastric Cancer and Metastatic HER2 Positive Gastroesophageal Junction Cancer, run by Shanghai Miracogen Inc. at 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer. Read more about this study

Who is it for?
Ages 18 years and older
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
60 participants
Where
3 sitesChina
Study dates
19 Jan 2022to 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to sign the ICF and follow the requirements specified in the protocol.
  • Aged ≥18.
  • Life expectancy ≥ 3 months.
  • Patients with histologically or cytologically confirmed gastric/ gastroesophageal junction cancer.
  • In Cohort 1, a positive HER2 test result defined as follows: IHC 3+ or IHC 2+ and ISH positive. In Cohort 2, low HER2 expression defined as follows: IHC 1+, or IHC 2+ and ISH negative.
  • Documented tumor progression or intolerance during or after at least one prior line of platinum- and/or fluoropyrimidine-based chemotherapy ± anti-HER2 (trastuzumab or equivalent) therapy.
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  • Willing and able to provide adequate archival tumor tissue samples for HER2 status confirmation by central laboratory.
  • Cohort 1 patients, who have received prior anti-HER2 therapy, are willing to undergo fresh tissue biopsy to confirm HER2 status as assessed by the investigator to be feasible and safe.
  • Patients must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • 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.
  • Organ function must meet the basic requirements.

Who cannot join

  • Patients with the following pathological diagnosis: squamous cell carcinoma, carcinoid tumor, neuroendocrine carcinoma, undifferentiated carcinoma, or other unclassifiable gastric cancer.
  • Peripheral neuropathy ≥ Grade 2 per CTCAE 5.0.
  • Prior treatment with HER2-targeted ADC.
  • Known allergic reaction to any component or excipient of MRG002, or known allergic reaction to trastuzumab or other prior anti-HER2 or other monoclonal antibodies ≥ Grade 3.
  • Presence of untreated or uncontrolled central nervous system (CNS) metastases.
  • Patients received chemotherapy, biological therapy, radical radiotherapy or other anti-tumor treatment within 3 weeks prior to the first dose of the study drug.
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  • Any severe cardiac dysfunction, history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment.
  • Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.
  • Tumor lesions with bleeding tendency or treated with blood transfusion within 2 weeks prior to the first dose of the study drug.
  • Toxicities due to prior anti-cancer therapy have not resolved to ≤ Grade 1 (CTCAE v5.0).
  • Concurrent malignancy within 5 years prior to enrollment.
  • Uncontrolled high blood pressure and diabetes.
  • History of ventricular tachycardia or torsades de pointes. Any clinically significant abnormalities in rhythm, conduction, or morphology on the resting ECG.
  • History of moderate to severe dyspnea at rest due to advanced cancer or its complications, severe primary lung disease, current need for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonitis.
  • Patients who had undergone thoracotomy, laparotomy, or surgery requiring general anesthesia without complete recovery within 4 weeks prior to the first dose of the study drug.
  • Active hepatitis B, active hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.
  • Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
  • Any severe and/or uncontrolled systemic diseases.
  • Use of systemic corticosteroids within 4 weeks prior to the first dose of study drug.
  • Use of potent CYP3A4 inhibitors or potent CYP3A4 inducers within 2 weeks prior to the first dose of study drug or need to continue during the study.
  • Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
  • Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Trial locations and contacts

3 sites in 1 country.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

China3 sites, 3 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100000

    Aiping Zhou, MD, 86-10-87788800, zhouap1825@126.com

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Zhenyang Liu, 18673181133, liuzhenyang@hnca.org.cn

    Recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200000

    Jin Li, MD, 021-3880-4518, lijin@csco.org.cn

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/ Gastroesophageal Junction Cancer.

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer.

Read the detailed description

There are two cohorts in this study. HER2-positive and HER2-low patients will be allocated to cohort 1 and cohort 2, respectively. When the 20th, 40th, or 60th patient in each cohort completed at least one post-baseline tumor assessment, the Safety Monitoring Committee will review the safety and efficacy of these patients to determine dose selection, enrollment continuation, study population, and sample size.

Being tested
MRG002
Keywords
MRG002, Antibody Drug Conjugate (ADC), HER2, Gastric/Gastroesophageal Junction Cancer

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 NCT05141747
Study groupRoleWhat they receive
MRG002ExperimentalMRG002 will be administrated by an IV infusion of 2.6 mg/kg 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)

    ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) according to RECIST v1.1.

    Measured: Baseline to study completion, up to 24 months

  2. 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 lase dose of study treatment.

Secondary outcomes (6)

  1. 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 24 months.

  2. 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 24 months.

  3. Duration of Response (DoR)

    DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause.

    Measured: Baseline to study completion, up to 24 months.

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion, up to 24 months.

  5. Pharmacokinetics (PK) Parameter of MRG002: 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

  6. 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 start19 Jan 2022
  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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141747
Sponsor's protocol ID
MRG002-007
Status last verified
Feb 2022
First submitted
19 Nov 2021
Last updated
23 Feb 2022
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 Locally Advanced Gastric Cancer and Metastatic HER2 Positive Gastroesophageal Junction Cancer, run by Shanghai Miracogen Inc. at 3 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 22 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 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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) (time frame: Baseline to study completion, up to 24 months). The study lists 2 primary outcomes in all. 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 NCT05141747.

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 23 Feb 2022.

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