A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer

Inclusion Criteria:

• Willing to sign the ICF and follow the requirements specified in the protocol.
• Age: ≥18 years，both genders.
• Expected survival time≥6 months.
• Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).
• Positive EGFR expression in tumor specimen.
• Failed in the prior second-line or above standard of care therapies.
• Archival or biopsy tumor specimens should be provided.
• Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
• ECOG performance score 0 or 1.
• AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).
• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
• Organ functions and coagulation function must meet the basic requirements.
• Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

• History of hypersensitivity to any component of the investigational product.
• No documented progression after prior treatment, or recurrence during or after prior treatment.
• Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.
• Presence of central nervous system metastasis.
• Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.
• Any severe or uncontrolled systemic disease judged by the investigator.
• Patients with poorly controlled heart diseases.
• Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
• Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.
• Prior history of other primary malignancies.
• History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
• History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.
• History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.
• Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
• Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
• History of allogeneic tissue or solid organ transplant.
• Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
• Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.
• Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.