a study to evaluate the efficacy and safety of mrg003 in patients with advanced gastric cancer.

Conditions: Advanced or Metastatic Gastric Cancer; Advanced or Metastatic Gastroesophageal Junction Carcinoma

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.

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.

Eligibility criteria:
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.

Keywords: mrg003 antibody drug conjugate (adc) gastric cancer egfr-positive, her2-negative