An Open-label, Multi-center, Non-randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).

Shanghai Miracogen Inc.1 site in 1 country100 target enrollmentDecember 2021

ConditionsNon-small- Cell Lung Cancer (NSCLC)

InterventionsMRG002

DrugsMRG002

Overview

Phase: Phase 2
Intervention: MRG002
Conditions: Non-small- Cell Lung Cancer (NSCLC)
Sponsor: Shanghai Miracogen Inc.
Enrollment: 100
Locations: 1
Primary Endpoint: Objective Response Rate (ORR) by Independent Review Committee (IRC)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Detailed Description

The trial consists of two stages: efficacy exploration and efficacy verification. At the first stage, at most 30 patients will be enrolled for each of the two cohorts as defined by HER2 mutation sites. If ≥8 patients achieved objective response, the second stage will be continued; otherwise the trial will be terminated. Approximately 40 patients will be enrolled in the second stage.

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

December 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Miracogen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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
•Known active infection, including hepatitis B, hepatitis C. Presence of other significant liver disease.

Arms & Interventions

MRG002

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

Intervention: MRG002

Outcomes

Primary Outcomes

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

Time Frame: Baseline to study completion (up to 12 months).

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

Secondary Outcomes

Progression Free Survival (PFS)(Baseline to study completion (up to 12 months).)
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).)
Overall Survival (OS)(Baseline to study completion (up to 12 months).)
Immunogenicity (ADA)(Baseline to 30 days after the last dose of study treatment.)
Adverse Events (AEs)(Baseline to 45 days after the last dose of study treatment.)
PK parameters: concentration-time curve(Baseline to 30 days after the last dose of study treatment.)