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

NCT04839510 | Unknown Phase 2

• 1 other identifier: MRG002-006
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 36

Brief Summary

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.

Conditions

Locally Advanced Urothelial Cancer; Metastatic Urothelial Carcinoma

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Urothelium Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to study completion, up to 12 months

Secondary Outcomes (9)

• ORR by Investigator

  Baseline to study completion, up to 12 months

• Duration of Response (DoR)

  Baseline to study completion, up to 12 months

• Time to Response (TTR)

  Baseline to study completion, up to 12 months

• Disease Control Rate (DCR)

  Baseline to study completion, up to 12 months

• Progression Free Survival (PFS)

  Baseline to study completion, up to 12 months

Study Arms (1)

MRG002

EXPERIMENTAL

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

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the ICF and follow the requirements specified in the protocol.
• Aged 18 to 75 (including 18 and 75), both genders.
• Expected survival time ≥ 12 weeks.
• Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.
• Failed in the prior one or more line of systemic chemotherapy.
• HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test.
• Archival or biopsy tumor specimens should be provided (primary or metastatic).
• Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• ECOG performance score 0 or 1.
• Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
• Organ function must meet the basic requirements.
• Coagulation function must meet the basic requirements.
• Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.

You may not qualify if:

• History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
• Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment.
• Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
• Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.
• Any severe or uncontrolled systemic diseases.
• Patients with poorly controlled heart diseases.
• Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
• History of other primary malignancies.
• History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• Peripheral neuropathy greater than Grade 1.
• History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
• Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
• Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
• Female patents 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (36)

Anhui provincial Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing hospital

Beijing, Beijing Municipality, 100005, China

NOT YET RECRUITING

Beijing Chao-Yang Hospital，Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

The Fifth Medical Center of the PLA

Beijing, Beijing Municipality, 100039, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Army Medical Center of PLA

Chongqing, Chongqing Municipality, 400042, China

TERMINATED

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

SUN Yat-sen university Cancer center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

ShenZhen Luohu People's Hospital

Shenzhen, Guangdong, 518005, China

TERMINATED

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

NOT YET RECRUITING

Liuzhou People's Hospital

Liuchow, Guangxi, 545026, China

RECRUITING

Haerbin medical university cancer hospital

Haerbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Union hospital tongji medical college huazhong univerity ofscience and technology

Wuhan, Hubei, 430022, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

TERMINATED

Xiangya hospital central south university

Changsha, Hunan, 410008, China

RECRUITING

The Affiliated Cancer Hospital of Xiangya School of Medicine(Hunan Cancer Hospital )

Changsha, Hunan, 410031, China

RECRUITING

Nantong Tumor Hospital

Nantong, Jiangsu, 226006, China

TERMINATED

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

RECRUITING

JiLinGuoWen Hospital

Siping, Jilin, 136199, China

RECRUITING

Liaoning Cancer hospital

Shenyang, Liaoning, 110042, China

RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, 810012, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Rui jin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200125, China

TERMINATED

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, 710061, China

RECRUITING

Sichuan provincial people's hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

The second Affiliated Hospital Zhejiang University School of Medical

Hangzhou, Zhejiang, 310003, China

RECRUITING

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, 310005, China

RECRUITING

The 1'Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Aiping Zhou, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: April 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (36)