Status:
UNKNOWN
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Advanced or Metastatic Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
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 obtain...
Eligibility Criteria
Inclusion
- 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.
- HER2 positive (IHC 3 + or IHC 2 +) 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
- History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
- Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.
- 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 interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Peripheral neuropathy greater than Grade 1.
- History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
- 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.
- 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.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04837508
Start Date
June 7 2021
End Date
August 1 2023
Last Update
December 10 2021
Active Locations (7)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233004
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280