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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

86

Phase

  • 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

Shanghai Miracogen Inc.

Investigators

  • 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)

June 7, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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