- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941339
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
December 2, 2021 updated by: Shanghai Miracogen Inc.
A Phase I, Open-label, Multi-center, First in Human, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2 Positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
Study Overview
Detailed Description
This study consists of two parts.
Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG002.
Phase Ib is a dose expansion study to further assess the efficacy and safety of MRG002 at confirmed RP2D.
Study Type
Interventional
Enrollment (Anticipated)
74
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200120
- Recruiting
- Shanghai Oriental Hospital
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Contact:
- Jin Li, Doctor
- Phone Number: 86-21-38804518
- Email: lijin@csco.org.cn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Understands and provides written informed consent and willing to follow the requirements specified in protocol;
- Both genders;
- Aged 18 to 75 (including 18 and 75);
- Expected survival time ≥ 12 weeks;
- Patients with histologically and/or cytologically confirmed HER2-positive solid tumors who have failed standard therapy or for whom no standard therapy exists or for whom standard therapy is not appropriate at current stage;
- Patients must have at least one evaluable lesion (Phase Ia) or measurable lesion (Phase Ib) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- The score of ECOG for performance status is 0 or 1;
- Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia);
- No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
- Organ functions must meet the basic requirements;
- Coagulation function must meet the basic requirements;
- Cumulative anthracycline dose ≤ 360 mg/m2 doxorubicin or its equivalent, 720 mg/m2 epirubicin.
Exclusion Criteria:
- Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;
- History of severe cardiac disease;
- Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;
- Patients with poorly controlled hypertension or clinically significant vascular disease;
- History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, or current need of continuous oxygen therapy, or any history of interstitial lung disease (ILD) or pneumonitis;
- Nausea and vomiting of any kind difficult to control, or chronic gastrointestinal disease;
- Patients with symptoms of central nervous system or brain metastasis or received treatment for central nervous system or brain metastasis within 3 months prior to the first dose of MRG002 treatment;
- Major surgery not fully recovery within 4 months prior to the first dose of MRG002 treatment;
- History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
- Evidence of active infection of hepatitis B or hepatitis C;
- History of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency disease, or history of organ transplantation;
- Any serious and/or uncontrolled disease or other condition that, considered by the investigator and sponsor, may compromise the patient's participation in this study;
- Received systemic corticosteroids within 4 weeks prior to the first dose of MRG002 treatment;
- Female patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
- Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRG002
All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG002 on Day 1 of every 3 weeks (21-day cycle).
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Administrated intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: DLT will be evaluated during the first treatment cycle (Day 1-28)
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The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT).
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DLT will be evaluated during the first treatment cycle (Day 1-28)
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Recommended Phase II Dose (RP2D)
Time Frame: Baseline to study completion (up to 6 months)
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The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
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Baseline to study completion (up to 6 months)
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Adverse Events (AEs)
Time Frame: Baseline to 49 days after the last dose of study treatment
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Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
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Baseline to 49 days after the last dose of study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: Baseline to study completion (up to 6 months)
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ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1.
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Baseline to study completion (up to 6 months)
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Duration of Response (DoR)
Time Frame: Baseline to study completion (up to 6 months)
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DoR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
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Baseline to study completion (up to 6 months)
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Progression Free Survival (PFS)
Time Frame: Baseline to study completion (up to 6 months)
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PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
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Baseline to study completion (up to 6 months)
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Pharmacokinetics (PK) parameter of MRG002: Cmax
Time Frame: Baseline to 21 days after the last dose of study treatment
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Maximum observed plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: Tmax
Time Frame: Baseline to 21 days after the last dose of study treatment
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Time to reach maximum plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: t1/2
Time Frame: Baseline to 21 days after the last dose of study treatment
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The time required for plasma concentration to decreased by on half.
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Baseline to 21 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG002: AUClast
Time Frame: Baseline to 21 days after the last dose of study treatment
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Area under the curve up to the last validated measurable plasma concentration.
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Baseline to 21 days after the last dose of study treatment
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Immunogenicity
Time Frame: Baseline to 21 days after the last dose of study treatment
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The proportion of patients with positive ADA immunogenicity results.
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Baseline to 21 days after the last dose of study treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jin Li, Doctor, Shanghai Oriental Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2018
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
June 20, 2021
First Submitted That Met QC Criteria
June 20, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRG002-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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