Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04838548
Start Date
September 4 2020
End Date
February 1 2023
Last Update
April 9 2021
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000