A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors

NCT ID: NCT04941339

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2022-10-31

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.

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.

Conditions

Advanced Solid Tumor

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

MRG002

Intervention Type: DRUG

Administrated intravenously

Interventions

MRG002

Administrated intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Understands and provides written informed consent and willing to follow the requirements specified in protocol;

2. Both genders;

3. Aged 18 to 75 (including 18 and 75);

4. Expected survival time ≥ 12 weeks;

5. 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;

6. 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);

7. The score of ECOG for performance status is 0 or 1;

8. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia);

9. No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;

10. Organ functions must meet the basic requirements;

11. Coagulation function must meet the basic requirements;

12. Cumulative anthracycline dose ≤ 360 mg/m2 doxorubicin or its equivalent, 720 mg/m2 epirubicin.

Exclusion Criteria

1. Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;

2. History of severe cardiac disease;

3. Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;

4. Patients with poorly controlled hypertension or clinically significant vascular disease;

5. 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;

6. Nausea and vomiting of any kind difficult to control, or chronic gastrointestinal disease;

7. 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;

8. Major surgery not fully recovery within 4 months prior to the first dose of MRG002 treatment;

9. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;

10. Evidence of active infection of hepatitis B or hepatitis C;

11. History of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency disease, or history of organ transplantation;

12. 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;

13. Received systemic corticosteroids within 4 weeks prior to the first dose of MRG002 treatment;

14. 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.

15. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Miracogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Oriental Hospital

Locations

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Program Director

Role: CONTACT

Phone: 86-21-61637960

Email: clinicaltrials@miracogen.com.cn

Facility Contacts

Jin Li, Doctor

Role: primary

Other Identifiers

MRG002-001

Identifier Type: -

Identifier Source: org_study_id