Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.
NCT05188209CI-TRIAL-00055938terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Why stopped (as posted): Study terminated due to sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Gastric Cancer | — | UNRESOLVED | — |
| Advanced or Metastatic Gastroesophageal Junction Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRG003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRG003
- description
- 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
- interventionNames
- Drug: MRG003
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) by Independent Review Committee (IRC)
- timeFrame
- Baseline to study completion (up to 24 months)
- description
- 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.
- measure
- Adverse Events (AEs)
- timeFrame
- Baseline to 30(for AE) and 45(for SAE) days after the last dose of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.