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Locally Advanced Urothelial CancerPhase 2NCT04839510

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

A Phase 2 study testing MRG002 in people with Locally Advanced Urothelial Cancer and Metastatic Urothelial Carcinoma, run by Shanghai Miracogen Inc. at 36 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MRG002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
36 sitesChina
Study dates
20 Apr 2021to Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

36 sites in 1 country.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

36 sites in 1 country

China36 sites, 31 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

    Aipingv Zhou, MD, 86-10-87788800, zhouap1825@126.com

    Recruiting

  • Beijing hospital

    Beijing, Beijing Municipality, 100005

    Ben Wan, 13701257342, Wanben2000@sina.com

    Not yet recruiting

  • Beijing Chao-Yang Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100020

    Yinong Niu, 18601020160, 18601020160@163.com

    Recruiting

  • The Fifth Medical Center of the PLA

    Beijing, Beijing Municipality, 100039

    Lijun Chen, 13910777307, chenlj829@163.com

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130061

    Ziling Liu, 13943001600, drzilingliu@163.com

    Recruiting

  • Xiangya hospital central south university

    Changsha, Hunan, 410008

    Minfeng Chen, 13517319380, chenminfeng1999@163.com

    Recruiting

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

    Changsha, Hunan, 410031

    Weiqing Han, 13875825253, md70210@sina.com

    Recruiting

  • Sichuan provincial people's hospital

    Chengdu, Sichuan, 610072

    Yong Liao, 18981838513, liaoyong616@sina.com

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Hong Luo, 13883029913, luodashu@sohu.com

    Recruiting

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality, 400042

    Terminated

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Yu Chen, 13859089836, 833392476@qq.com

    Not yet recruiting

  • SUN Yat-sen university Cancer center

    Guangzhou, Guangdong, 510060

    Fangjian Zhou, 13922735659, zhoufj@sysucc.org.cn

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Yongda Liu, 18922347906, 13719007083@163.com

    Recruiting

  • Haerbin medical university cancer hospital

    Haerbin, Heilongjiang, 150081

    Hui Chen, 13603612355, erchenhui@hotmail.com

    Recruiting

  • The second Affiliated Hospital Zhejiang University School of Medical

    Hangzhou, Zhejiang, 310003

    Jimin Chen, 13575731457, cjm6300@126.com

    Recruiting

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

    Hangzhou, Zhejiang, 310005

    Shaoxing Zhu, 18758872716, zsxing2005@126.com

    Recruiting

  • Anhui provincial Cancer Hospital

    Hefei, Anhui, 230031

    Changlu Hu, 15555426636, 13955116061@139.com

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Dexin Yu, 13705690883, yudx_urology@126.com

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Benkang Shi, 13969006388, bkshi68@163.com

    Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545026

    Pei Lu, 18037132111, lylpnh@126.com

    Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226006

    Terminated

  • Rui jin hospital

    Shanghai, Shanghai Municipality, 200025

    Danfeng Xu, 13901734568, xu-danfeng@hotmail.com

    Recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200125

    Terminated

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Chuanliang Xu, 13816323268, chuanliang_xu@126.com

    Not yet recruiting

  • Liaoning Cancer hospital

    Shenyang, Liaoning, 110042

    Cheng Fu, 18900917622, 13840219900@163.com

    Recruiting

  • ShenZhen Luohu People's Hospital

    Shenzhen, Guangdong, 518005

    Terminated

  • JiLinGuoWen Hospital

    Siping, Jilin, 136199

    Jizhong Quan, 15774496522, quanjizhong@jlguowen.com

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300181

    Xin Yao, 13803000688, yaoxin@tjmuch.com

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Hailong Hu, 13662096232, Hhllove2004@163.com

    Recruiting

  • The 1'Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

    Zhiliang Weng, 13806889501, wengzL2001@163.com

    Recruiting

  • Union hospital tongji medical college huazhong univerity ofscience and technology

    Wuhan, Hubei, 430022

    Guiling Li, 13307187507, Lgl6714@163.com

    Recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Terminated

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi, 710061

    Lei Li, 15991752560, Lilydr@163.com

    Recruiting

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810012

    Guojun Chen, 13897283691, chenguojun68@126.com

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Shujun Yang, 13803869419, nykang@126.com

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Hongyu Zhang, 13928075391, zdwyzhy@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
MRG002
Keywords
MRG002, Antibody Drug Conjugate (ADC), HER2, Urothelium Cancer
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG002Drug

    Administrated intravenously

Study groups in NCT04839510
Study groupRoleWhat they receive
MRG002ExperimentalMRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG002

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to study completion, up to 12 months

Secondary outcomes (9)

  1. ORR by Investigator

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

    Measured: Baseline to study completion, up to 12 months

  2. Duration of Response (DoR)

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

    Measured: Baseline to study completion, up to 12 months

  3. Time to Response (TTR)

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

    Measured: Baseline to study completion, up to 12 months

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion, up to 12 months

  5. Progression Free Survival (PFS)

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

    Measured: Baseline to study completion, up to 12 months

  6. Overall Survival (OS)

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

    Measured: Baseline to study completion, up to 12 months

  7. Adverse Events (AEs)

    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.

    Measured: Baseline to 30 days after the last dose of study treatment

  8. Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve

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

    Measured: Baseline to 30 days after the last dose of study treatment

  9. Incidence of anti-drug antibody (ADA)

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

    Measured: Baseline to 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start20 Apr 2021
  3. Primary completionJun 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04839510
Sponsor's protocol ID
MRG002-006
Status last verified
Dec 2021
First submitted
6 Apr 2021
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG002 in people with Locally Advanced Urothelial Cancer and Metastatic Urothelial Carcinoma, run by Shanghai Miracogen Inc. at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Baseline to study completion, up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04839510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

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