AzTrials
AzTrials

Advanced or Metastatic Gastric CancerPhase 2NCT05188209

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

A Phase 2 study testing MRG003 in people with Advanced or Metastatic Gastric Cancer and Advanced or Metastatic Gastroesophageal Junction Carcinoma, run by Lepu Biopharma Co., Ltd. at 5 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MRG003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
5 sitesChina
Study dates
31 Dec 2021to 12 Oct 2022
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 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • - 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Tumor Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
MRG003
Keywords
MRG003, Antibody Drug Conjugate (ADC), Gastric Cancer, EGFR-positive, HER2-negative
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG003Drug

    Administered intravenously

Study groups in NCT05188209
Study groupRoleWhat they receive
MRG003ExperimentalOn 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
Receives: Drug: MRG003

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 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.

    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 30(for AE) and 45(for SAE) days after the last dose of study treatment

Secondary outcomes (12)

  1. Objective Response Rate (ORR) by Investigator

    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.

    Measured: Baseline to study completion (up to 24 months)

  2. 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)

  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 24 months)

  4. Disease Control Rate (DCR)

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

    Measured: Baseline to study completion (up to 24 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 24 months)

  6. PK parameter for MRG003: (Cmax)

    Maximum observed plasma concentration.

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

  7. PK parameter for MRG003: (AUClast)

    Area under the curve up to the last validated measurable plasma concentration

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

  8. PK parameter for total antibody (TAb): Cmax

    Maximum observed plasma concentration.

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

  9. PK parameter for TAb: AUClast

    Area under the curve up to the last validated measurable plasma concentration

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

  10. PK parameter for Monomethyl Auristatin E (MMAE): Cmax

    Maximum observed plasma concentration.

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

  11. PK parameter for MMAE: AUClast

    Area under the curve up to the last validated measurable plasma concentration

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

  12. The proportion of patients with positive of anti-drug antibody (ADA)

    The proportion of patients with positive ADA immunogenicity 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 posted12 Jan 2022
  2. Study start31 Dec 2021
  3. Primary completion12 Oct 2022
  4. Study completion12 Oct 2022

Why it stopped: Study terminated due to sponsor decision

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188209
Sponsor's protocol ID
MRG003-006
Status last verified
Sep 2026
First submitted
5 Jan 2022
Last updated
9 Sep 2026
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 MRG003 in people with Advanced or Metastatic Gastric Cancer and Advanced or Metastatic Gastroesophageal Junction Carcinoma, run by Lepu Biopharma Co., Ltd. at 5 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 27 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: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study was stopped early (reason given: Study terminated due to sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 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 NCT05188209.

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 9 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in