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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839510
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Miracogen Inc.

Study Description
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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
Locally Advanced Urothelial Cancer Metastatic Urothelial Carcinoma Drug: MRG002 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 20, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) by Independent Review Committee (IRC) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839510


Contacts
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Contact: Program Director 86-21-61637960 clinicaltrials@miracogen.com.cn

Locations
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Sponsors and Collaborators
Shanghai Miracogen Inc.
Investigators
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Principal Investigator: Aiping Zhou, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Shanghai Miracogen Inc.
ClinicalTrials.gov Identifier: NCT04839510    
Other Study ID Numbers: MRG002-006
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms