- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838964
A Study of MRG003 in the Treatment of EGFR-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 MRG003 in the Treatment of Patients With EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior standard therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 MRG003.
Based on the 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 initial 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 MRG003.
Study Type
Interventional
Enrollment (Anticipated)
80
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
-
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Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Cancer Hospital Chinese Academy of Medical Sciences
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Contact:
- Aiping Zhou, MD
- Phone Number: 86-10-87788800
- Email: zhouap1825@126.com
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Beijing, Beijing, China, 100007
- Recruiting
- Beijing Youan Hospital,Capital Medical University
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Contact:
- Chunwang Yuan
- Phone Number: 86-10-83997322
- Email: 18612778605@163.com
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Fujian
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Xiamen, Fujian, China, 361003
- Recruiting
- The First Affiliated Hospital of Xiamen University
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Contact:
- Jiayi Li
- Phone Number: 86-592-3127572
- Email: ljy778848@qq.com
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Recruiting
- Harbin Medical University Cancer Hospital
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Contact:
- Yanqiao Zhang
- Phone Number: 86-451-86298192
- Email: yanqiaozhang@126.com
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Henan
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Zhengzhou, Henan, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
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Contact:
- Yanru Qin
- Phone Number: 86-371-88122482
- Email: yanruqin@163.com
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Hunan
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Changsha, Hunan, China, 410031
- Recruiting
- Hunan Cancer Hospital
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Contact:
- Shanzhi Gu
- Phone Number: 86-731-89762695
- Email: gushanzhi@hnca.org.cn
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Jilin
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Changchun, Jilin, China, 130061
- Recruiting
- Bethune First Hospital of Jilin University
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Contact:
- Wei Li
- Phone Number: 86-431-88786014
- Email: jdyylw@163.com
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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:
- 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 biliary tract cancer confirmed by histopathology.
- Failed in the prior one or more standard therapies.
- EGFR positive in the tumor specimens confirmed by central laboratory test.
- 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.
Exclusion Criteria:
- History of hypersensitivity to any component of MRG003.
- Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose.
- Presence of clinical manifestation of biliary obstruction.
- Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
- Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
- Any severe or uncontrolled systemic diseases.
- Patients with poorly controlled heart diseases.
- 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 the following ophthalmologic abnormalities:severe dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
- History of severe skin disease or chronic skin disease requiring oral or intravenous treatment.
- History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Peripheral neuropathy greater than Grade 1.
- 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.
- History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
- 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.
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: MRG003
MRG003 will be administrated via IV infusion at 2.0 mg/kg on Day 1 of every 3 weeks (21-day cycle).
|
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.
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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
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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
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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.
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Baseline to 30 days after the last dose of study treatment
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Incidence of anti-drug antibody (ADA)
Time Frame: Baseline to 30 days after the last dose of study treatment
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The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment.
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Baseline to 30 days after the last dose of study treatment
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Pharmacokinetics (PK) parameter of MRG003: concentration-time curve
Time Frame: Baseline to 30 days after the last dose of study treatment
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Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).
|
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
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)
April 28, 2021
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
April 6, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 9, 2021
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 8, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRG003-003
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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