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

Sponsor
Shanghai Miracogen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04839510
Collaborator
(none)
58
Enrollment
36
Locations
1
Arm
16.4
Anticipated Duration (Months)
1.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MRG002

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
Administrated intravenously

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate (ORR) by Independent Review Committee (IRC) [Baseline to study completion, up to 12 months]

    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.

Secondary Outcome Measures

  1. ORR by Investigator [Baseline to study completion, up to 12 months]

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

  2. Duration of Response (DoR) [Baseline to study completion, up to 12 months]

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

  3. Time to Response (TTR) [Baseline to study completion, up to 12 months]

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

  4. Disease Control Rate (DCR) [Baseline to study completion, up to 12 months]

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

  5. Progression Free Survival (PFS) [Baseline to study completion, up to 12 months]

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

  6. Overall Survival (OS) [Baseline to study completion, up to 12 months]

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

  7. Adverse Events (AEs) [Baseline to 30 days after the last dose of study treatment]

    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.

  8. Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve [Baseline to 30 days after the last dose of study treatment]

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

  9. Incidence of anti-drug antibody (ADA) [Baseline to 30 days after the last dose of study treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Willing to sign the ICF and follow the requirements specified in the protocol.

  2. Aged 18 to 75 (including 18 and 75), both genders.

  3. Expected survival time ≥ 12 weeks.

  4. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.

  5. Failed in the prior one or more line of systemic chemotherapy.

  6. HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test.

  7. Archival or biopsy tumor specimens should be provided (primary or metastatic).

  8. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  9. ECOG performance score 0 or 1.

  10. 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).

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

  12. Organ function must meet the basic requirements.

  13. Coagulation function must meet the basic requirements.

  14. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

  1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.

  2. Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment.

  3. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.

  4. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.

  5. Any severe or uncontrolled systemic diseases.

  6. Patients with poorly controlled heart diseases.

  7. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.

  8. History of other primary malignancies.

  9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.

  10. Peripheral neuropathy greater than Grade 1.

  11. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).

  12. 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.

  13. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.

  14. 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui provincial Cancer Hospital Hefei Anhui China 230031
2 The Second Hospital of Anhui Medical University Hefei Anhui China 230601
3 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100000
4 Beijing hospital Beijing Beijing China 100005
5 Beijing Chao-Yang Hospital，Capital Medical University Beijing Beijing China 100020
6 The Fifth Medical Center of the PLA Beijing Beijing China 100039
7 Chongqing University Cancer Hospital Chongqing Chongqing China 400030
8 Army Medical Center of PLA Chongqing Chongqing China 400042
9 Fujian Cancer Hospital Fuzhou Fujian China 350014
10 SUN Yat-sen university Cancer center Guangzhou Guangdong China 510060
11 The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510120
12 ShenZhen Luohu People's Hospital ShenZhen Guangdong China 518005
13 The Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong China 519000
14 Liuzhou People's Hospital Liuzhou Guangxi China 545026
15 Haerbin medical university cancer hospital Haerbin Heilongjiang China 150081
16 Henan Cancer Hospital Zhengzhou Henan China 450003
17 Union hospital tongji medical college huazhong univerity ofscience and technology Wuhan Hubei China 430022
18 Tongji Hospital Wuhan Hubei China 430030
19 Xiangya hospital central south university Changsha Hunan China 410008
20 The Affiliated Cancer Hospital of Xiangya School of Medicine(Hunan Cancer Hospital ) Changsha Hunan China 410031
21 Nantong Tumor Hospital Nantong Jiangsu China 226006
22 The First Hospital of Jilin University Changchun Jilin China 130061
23 JiLinGuoWen Hospital Siping Jilin China 136199
24 Liaoning Cancer hospital Shenyang Liaoning China 110042
25 Qinghai University Affiliated Hospital Xining Qinghai China 810012
26 Qilu Hospital of Shandong University Jinan Shandong China 250012
27 Rui jin hospital Shanghai Shanghai China 200025
28 Zhongshan Hospital Affiliated to Fudan University Shanghai Shanghai China 200125
29 Changhai Hospital Shanghai Shanghai China 200433
30 First Affiliated Hospital of Xi'an Jiaotong University Xian Shanxi China 710061
31 Sichuan provincial people's hospital Chengdu Sichuan China 610072
32 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300181
33 The Second Hospital of Tianjin Medical University Tianjin Tianjin China 300211
34 The second Affiliated Hospital Zhejiang University School of Medical Hangzhou Zhejiang China 310003
35 Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) Hangzhou Zhejiang China 310005
36 The 1'Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325015

Sponsors and Collaborators

  • Shanghai Miracogen Inc.

Investigators

  • Principal Investigator: Aiping Zhou, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Miracogen Inc.
ClinicalTrials.gov Identifier:
NCT04839510
Other Study ID Numbers:
  • MRG002-006
First Posted:
Apr 9, 2021
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Miracogen Inc.
MRG002
Antibody Drug Conjugate (ADC)
HER2
Urothelium Cancer
Additional relevant MeSH terms:
Carcinoma, Transitional Cell

Study Results

No Results Posted as of Dec 14, 2021