a study to evaluate the efficacy and safety of mrg003 in patients with egfr-positive advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: 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


Eligibility criteria:
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.

Keywords: mrg003 antibody drug conjugate (adc) egfr non-small cell lung cancer (nsclc)