A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

NCT05141786 | Unknown Phase 2

• 1 other identifier: MRG002-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-mutated unresectable or metastatic non-small-cell lung cancer (NSCLC).

Conditions

Non-small- Cell Lung Cancer (NSCLC)

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Non-small-cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Independent Review Committee (IRC)

  ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.

  Baseline to study completion (up to 12 months).

Secondary Outcomes (8)

• ORR by Investigator

  Baseline to study completion (up to 12 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 12 months).

• Duration of Response (DOR)

  Baseline to study completion (up to 12 months).

• Progression Free Survival (PFS)

  Baseline to study completion (up to 12 months).

• Overall Survival (OS)

  Baseline to study completion (up to 12 months).

Study Arms (1)

MRG002

EXPERIMENTAL

MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understands and provides written informed consent and willing to follow the requirements specified in protocol.
• Aged 18 to 75 (including 18 and 75), both genders;
• Life expectancy ≥ 3 months;
• Advanced NSCLC patients with HER2 mutation in tumor tissue/blood confirmed by NGS/PCR methods. If no prior test results, a tumor tissue specimen from the most recent archival or biopsy (if archival tissue is not available or sufficient) should be provided.
• Histologically and/or cytologically confirmed unresectable locally advanced or NSCLC with histological subtype of either non-squamous cell carcinoma or squamous cell carcinoma, and patients have at least one measurable lesion as defined by RECIST v1.1.
• Patients who have failed at least one prior line of Stand of Care (SOC) therapy. Those who refuse or cannot tolerate chemotherapy can also be enrolled.
• The score of ECOG for performance status is 0 or 1 with no deterioration within 2 weeks prior to the first dose of the study drug.
• Radiographic evidence of tumor progression during or after the most recent therapy confirmed by investigator.
• Organ functions must meet the basic requirements.
• A negative serum or urine pregnancy test within 72 hours of receiving the first dose of study treatment. A serum pregnancy test is required if the urine pregnancy test is positive or cannot be confirmed negative. Women who are pregnant or breast feeding should be excluded.
• Adequate contraception for women of childbearing potential is defined as hormonal birth control or an intrauterine device and willingness to use 2 methods of contraception or be surgically sterile, or abstain from hetero sexual activity for the course of the study through 120 days after receiving the last dose of study medications.
• Male patients must be willing to use a latex condom during any sexual contact with females of childbearing potential during and for 120 days after the last infusion of MRG002, even after having undergone a successful vasectomy.

You may not qualify if:

• Prior treatment with HER2-targeted ADC or HER2 targeted antibody.
• Histologically/cytologically confirmed small-cell lung cancer (SCLC) and mixed type of lung cancer with SCLC histopathology.
• Received systemic cytotoxic chemotherapy, small molecule targeted drugs within 3 weeks before the first dose of the study drug; received anti-tumor biological therapy, immunotherapy or major surgery within 4 weeks before first dose of the study drug. Use of any other type of anti-cancer therapy is prohibited throughout the study.
• Known active CNS metastases and/or carcinomatous meningitis.
• Presence of severe cardiac dysfunction within 6 months of enrollment.
• Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.
• Known history of malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
• Uncontrolled or poorly controlled hypertension. Patients with active bleeding, history of coagulation disorder, or on Coumarin anticoagulant.
• Known allergic reactions to any component or excipient of MRG002, or known allergic reaction to other prior anti-HER2 (including investigational) or to other monoclonal antibodies ≥ Grade 3.
• Known active infection, including hepatitis B, hepatitis C. Presence of other significant liver disease.
• Concurrent, serious, uncontrolled infection or known infection with human immunodeficiency virus (HIV), or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune diseases; or previously undergone allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or has previously received a solid organ transplantation.
• Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection and has not received systemic antibiotics within 14 days unless treated and resolved prior to study treatment.
• Received a live-viral vaccination within 30 days prior to the first dose of the study drug. Seasonal influenza or approved COVID-19 vaccines that do not contain live virus are allowed.
• History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, current need for continuous oxygen therapy, or any history of interstitial lung disease or pneumonia that required oral or intravenous glucocorticoids to assist with management.
• Patients who are receiving immunologically based therapy for any reason.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

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

• Shun Lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

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: November 19, 2021
• First Posted: December 2, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)