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

NCT04838548 | Unknown Phase 2

• 1 other identifier: MRG003-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

MRG003; Antibody Drug Conjugate (ADC); EGFR; Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Investigator

  ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

  Baseline to study completion, up to 12 months

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Baseline to study completion, up to 12 months

• Duration of Response (DoR)

  Baseline to study completion, up to 12 months

• Time to Response (TTR)

  Baseline to study completion, up to 12 months

• Disease Control Rate (DCR)

  Baseline to study completion, up to 12 months

• Overall Survival (OS)

  Baseline to study completion, up to 12 months

Study Arms (1)

MRG003

EXPERIMENTAL

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

Drug: MRG003

Interventions

MRG003 DRUG

Administered intravenously

MRG003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuankai Shi, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director, Master

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: September 4, 2020
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)