Clinical trial NCT04838548: A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: MRG003
Antibody Drug Conjugate (ADC)
EGFR
Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Shanghai Miracogen Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Objective Response Rate (ORR) by Investigator
timeFrame: Baseline to study completion, up to 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline to study completion, up to 12 months
measure: Duration of Response (DoR)
timeFrame: Baseline to study completion, up to 12 months
measure: Time to Response (TTR)
timeFrame: Baseline to study completion, up to 12 months
measure: Disease Control Rate (DCR)
timeFrame: Baseline to study completion, up to 12 months
measure: Overall Survival (OS)
timeFrame: Baseline to study completion, up to 12 months
measure: Adverse Events (AEs)
timeFrame: Baseline to 60 days after the last dose of study treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: