Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).

MRG002

Program Director

Changlu Hu

Dexin Yu

Aipingv Zhou, MD

Ben Wan

Yinong Niu

Lijun Chen

Hong Luo

Yu Chen

Fangjian Zhou

Yongda Liu

Hongyu Zhang

Pei Lu

Hui Chen

Shujun Yang

Guiling Li

Minfeng Chen

Weiqing Han

Ziling Liu

Jizhong Quan

Cheng Fu

Guojun Chen

Benkang Shi

Danfeng Xu

Chuanliang Xu

Lei Li

Yong Liao

Xin Yao

Hailong Hu

Jimin Chen

Shaoxing Zhu

Zhiliang Weng

Aiping Zhou, MD

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive unresectable locally advanced or metastatic urothelium cancer.

The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of second stage Phase IIb single-arm study either will be continued or the trail will be terminated. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 33 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.

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

An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer

ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1.

ORR is defined as the percentage of patients with CR and PR as assessed by Investigator according to RECIST v1.1.

DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause.

TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

DCR is defined as the percentage of patients who achieve 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.

Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).

The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment.

Shanghai Miracogen Inc.

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Pemetrexed

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

MRG002 will be administrated by an IV infusion of 2.2 mg/kg on Day 1 of every 3 weeks (21-day cycle).

Docetaxel injection will be administered by an IV infusion of 75 mg/m2 on Day 1 of every 3 weeks (21-day cycle); Paclitaxel will be administrated by an IV infusion of 175 mg/m2 on Day 1 of every 3 weeks (21-day cycle).

Gemcitabine Hydrochloride will be administrated by an IV infusion of 1000 mg/m2 on Day 1 and Day 8 of every 3 weeks (21-day cycle).

Pemetrexed Disodium will be administrated by an IV infusion of 500 mg/m2 on Day 1 of every 3 weeks (21-day cycle).

Docetaxel Injection

Paclitaxel Injection

Gemcitabine Hydrochloride for Injection

Pemetrexed Disodium Injection

Fangjian Zhou, MD

The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors.

This study aims to enroll 290 patients. Participants will be randomly assigned to receive treatment of MRG002 or investigator selected chemotherapy in a 1:1 ratio. The efficacy of MRG002 will be assessed by patient's OS, PFS and other indicators as compared to investigator selected chemotherapy. Additionally, this study will assess the pharmacokinetic profile, immunogenicity, safety, tolerability, and treatment compliance of MRG002.

A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer

An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1/PD-L1 Inhibitors

OS is defined as the time from the date of randomization until death of any cause.

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

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 percentage of patients who achieve CR, PR, and stable disease (SD).

CBR is defined as the percentage of patients who achieve CR, PR, and SD for ≥ 6 months.

TTR is defined as the duration from randomization to the first documented objective response (CR/PR).

Plot of drug concentration changing with time after drug administration.

The proportion of patients with positive ADA results and its titer.

The proportion of patients with positive NAb results and its titer.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Cisplatin

Sorafenib

Protein Kinase Inhibitors

Placebo

Susanne Krege, Prof. Dr.

The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine and cisplatin in bladder cancer.

A controlled, double-blind, randomized study to evaluate the influence of Sorafenib in bladder cancer patients additionally to chemotherapy with gemcitabine and cisplatin compared to placebo.

Sorafenib in Urothelium Cancer of Bladder

Prospektiv, Randomisierte, Doppelblinde, Multizentrische Phase-II- Studie Zum Vergleich Der Wirksamkeit Einer Chemotherapie Mit Gemcitabin Plus Cisplatin Und Sorafenib (BAY 43-9006) Versus Gemcitabin Plus Cisplatin Und Plazebo in Der Therapie Des Lokal Fortgeschrittenen Bzw. Metastasierten Urothelkarzinoms AB 31/05 - RUTT 204 - SUSE

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer	NCT04839510	Locally Advance... Metastatic Urot...	MRG002	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer	NCT05754853	Advanced or Met...	MRG002 Docetaxel Injec... Paclitaxel Inje... Gemcitabine Hyd... Pemetrexed Diso...	18 Years - 75 Years	Shanghai Miracogen Inc.
Sorafenib in Urothelium Cancer of Bladder	NCT01215266	Bladder Cancer	Sorafenib Placebo	18 Years -	Association of Urologic Oncology (AUO)

Spots Global Cancer Trial Database for urothelium cancer