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

December 8, 2021 updated by: Shanghai Miracogen Inc.

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 Biliary Tract Cancer

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital&Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 biliary tract cancer confirmed by histopathology.
  5. Failed in the prior one or more standard therapies.
  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 chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.
  3. Presence of clinical manifestation of biliary obstruction.
  4. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
  5. Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
  6. Any severe or uncontrolled systemic diseases.
  7. Patients with poorly controlled heart diseases.
  8. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
  9. History of other primary malignancies.
  10. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
  11. Peripheral neuropathy greater than Grade 1.
  12. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
  13. 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.
  14. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
  15. 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.
  16. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 a 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR by Investigator
Time Frame: Baseline to study completion, up to 12 months
ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1.
Baseline to study completion, up to 12 months
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.
Baseline to study completion, up to 12 months
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.
Baseline to study completion, up to 12 months
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.
Baseline to study completion, up to 12 months
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.
Baseline to study completion, up to 12 months
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.
Baseline to study completion, up to 12 months
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.
Baseline to 30 days after the last dose of study treatment
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).
Baseline to 30 days after the last dose of study treatment
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.
Baseline to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Miracogen Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aiping Zhou, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRG002-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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