Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Ado-Trastuzumab Emtansine

Trastuzumab

Antibodies

Immunoglobulins

Adenosine

Maytansine

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

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

Trastuzumab Emtansine for Injection will be administrated via intravenous infusion of 3.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

MRG002

Trastuzumab Emtansine for Injection

Program Director

Zefei Jiang, Doctor

Hongyan Ying

Yunjiang Liu, Doctor

Yuanting Gu

Qun Li

Xian Wang

Yunjinang Liu, Doctor

The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary objective of Phase III is to evaluate the efficacy and safety of MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have been previously treated with trastuzumab (or a biosimilar) and an anti-HER2 tyrosine kinase inhibitor (anti-HER2-TKI) and have progressed on or after the most recent therapy.

A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause assessed by Independent Review Committee (IRC) according to RECIST v1.1.

ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.

DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.

DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

OS is defined as the duration from the start of treatment to death of any cause.

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.

Plot of drug concentration changing with time after drug administration.

The proportion of patients with positive ADA immunogenicity results.

Shanghai Miracogen Inc.

Rare Diseases

Myotonic Dystrophy Type 1

Maleic acid

Trastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death.

3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle;

The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle;

Pyrotinib Maleate Tablets

Chunfang Hao, PhD

This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.

Female patients with advanced breast cancer aged ≥18 years and ≤75 years old

Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer	NCT04924699	Advanced Breast... Metastatic Brea...	MRG002 Trastuzumab Emt...	18 Years - 75 Years	Shanghai Miracogen Inc.
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy	NCT05560308	HER2+ Advanced ...	Trastuzumab Emt... Pyrotinib Malea...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital

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