A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
NCT ID: NCT04837508
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
86 participants
INTERVENTIONAL
2021-06-07
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MRG002
MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).
MRG002
Administrated intravenously
Interventions
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MRG002
Administrated intravenously
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Miracogen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aiping Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Mingxi Wang
Role: primary
Aiping Zhou, MD
Role: primary
Mei Guan
Role: primary
Weimin Ding
Role: primary
Yanqiao Zhang
Role: primary
Ying Liu
Role: primary
Jingdong Zhang
Role: primary
Other Identifiers
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MRG002-002
Identifier Type: -
Identifier Source: org_study_id