A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.

September 4, 2026 updated by: Lepu Biopharma Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
        • Henan Tumor Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Willing to sign the ICF and follow the requirements specified in the protocol.
  • Age: 18-75 years (including 18 and 75), both genders.
  • Expected survival time≥3 months.
  • Patients with histologically confirmed inoperable locally advanced or metastatic gastric adenocarcinoma.
  • Tumor tissue must be EGFR positive and HER2 negative.
  • Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • ECOG performance score 0 or 1.
  • Organ functions and coagulation function must meet the basic requirements.
  • No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
  • Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.
  • Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

  • - Squamous cell carcinoma, carcinoid, neuroendocrine carcinoma, undifferentiated carcinoma, or other gastric cancers,or adenocarcinoma with other pathological components that cannot be classified, or adenocarcin oma accompanied by other pathological components.
  • History of hypersensitivity to any component of the study drug or to other EGFR-targeting agents.
  • Antitumor biological therapy or immunotherapy, targeted small molecule therapy and have history of systemic chemotherapy within 4 weeks before the first administration of the investigational drug, or major surgery. Traditional Chinese medicine, Chinese patent medicine or traditional Chinese medicine formula with anti-tumor effect should not be used within 2 weeks before the first administration.
  • Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.
  • Known active CNS metastasis.
  • Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.
  • Patients with intestinal obstruction requiring treatment were excluded.
  • Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0).

Peripheral neuropathy ≥ Grade 2 (NCICTCAE version 5.0).

  • Uncontrolled or poorly controlled hypertension.
  • Uncontrolled or poorly controlled heart disease.
  • Known active hepatitis B or C.
  • Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.
  • Known history of malignancy.
  • History of ophthalmologic abnormalities
  • History of severe skin disease
  • Moderate to severe dyspnea at rest caused by advanced cancer or its complications, or severe primary lung disease, oxygen saturation < 93% in non-oxygen state, or history of any interstitial lung disease or interstitial lung disease (ILD) requiring oral or intravenous glucocorticoids or non-infectious pneumonia.
  • Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.
  • History of pulmonary embolism or deep vein thrombosis within 6 months before the first administration of the investigational drug.
  • Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.

Decompensated cirrhosis of Child-Pugh class B, C

  • Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.
  • Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.
  • Uncontrolled intercurrent illness
  • Patients requiring parenteral nutrition within 4 weeks
  • Women who are lactating or pregnant.
  • Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MRG003
On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight
Drug: MRG003
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Independent Review Committee (IRC)
Time Frame: Baseline to study completion (up to 24 months)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.
Baseline to study completion (up to 24 months)
Adverse Events (AEs)
Time Frame: Baseline to 30(for AE) and 45(for SAE) days after the last dose of study treatment
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.
Baseline to 30(for AE) and 45(for SAE) days after the last dose of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Investigator
Time Frame: Baseline to study completion (up to 24 months)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
Baseline to study completion (up to 24 months)
Progression Free Survival (PFS)
Time Frame: Baseline to study completion (up to 24 months)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Baseline to study completion (up to 24 months)
Duration of Response (DoR)
Time Frame: Baseline to study completion (up to 24 months)
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.
Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
Time Frame: Baseline to study completion (up to 24 months)
DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.
Baseline to study completion (up to 24 months)
Overall Survival (OS)
Time Frame: Baseline to study completion (up to 24 months)
OS is defined as the duration from the start of treatment to death of any cause.
Baseline to study completion (up to 24 months)
PK parameter for MRG003: (Cmax)
Time Frame: Baseline to 30 days after the last dose of study treatment
Maximum observed plasma concentration.
Baseline to 30 days after the last dose of study treatment
PK parameter for MRG003: (AUClast)
Time Frame: Baseline to 30 days after the last dose of study treatment
Area under the curve up to the last validated measurable plasma concentration
Baseline to 30 days after the last dose of study treatment
PK parameter for total antibody (TAb): Cmax
Time Frame: Baseline to 30 days after the last dose of study treatment
Maximum observed plasma concentration.
Baseline to 30 days after the last dose of study treatment
PK parameter for TAb: AUClast
Time Frame: Baseline to 30 days after the last dose of study treatment
Area under the curve up to the last validated measurable plasma concentration
Baseline to 30 days after the last dose of study treatment
PK parameter for Monomethyl Auristatin E (MMAE): Cmax
Time Frame: Baseline to 30 days after the last dose of study treatment
Maximum observed plasma concentration.
Baseline to 30 days after the last dose of study treatment
PK parameter for MMAE: AUClast
Time Frame: Baseline to 30 days after the last dose of study treatment
Area under the curve up to the last validated measurable plasma concentration
Baseline to 30 days after the last dose of study treatment
The proportion of patients with positive of anti-drug antibody (ADA)
Time Frame: Baseline to 30 days after the last dose of study treatment
The proportion of patients with positive ADA immunogenicity results.
Baseline to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lepu Biopharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aiping Zhou, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRG003-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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