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

  • STATUS
    Recruiting
  • End date
    Aug 18, 2023
  • participants needed
    86
  • sponsor
    Shanghai Miracogen Inc.
Updated on 18 December 2021

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 cancer patients who have progressed during or relapsed after at least one prior stand therapy.

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.

Details
Condition Advanced or Metastatic Biliary Tract Cancer
Treatment MRG002
Clinical Study IdentifierNCT04837508
SponsorShanghai Miracogen Inc.
Last Modified on18 December 2021

Eligibility

Yes No Not Sure

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
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 Criteria

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
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