Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Advanced or Metastatic Gastric Cancer
Advanced or Metastatic Gastroesophageal Junction Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 g...
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 recei...
Eligibility Criteria
Inclusion
- \- 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
- \- 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.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05188209
Start Date
May 24 2021
End Date
August 1 2023
Last Update
January 12 2022
Active Locations (5)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
2
Henan Tumor Hospital
Zhengzhou, Henan, China
3
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
4
Jinan Central Hospital
Jinan, Shandong, China, 250013