Status:
UNKNOWN
A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer
Lead Sponsor:
Shanghai Miracogen Inc.
Conditions:
Locally Advanced Urothelial Cancer
Metastatic Urothelial Carcinoma
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 patients with HER2-positive unresectable locally advanced or metastatic...
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 MRG002. Based on the initial safety and efficacy data ob...
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 urothelium cancer confirmed by histopathology.
- Failed in the prior one or more line of systemic chemotherapy.
- 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 radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose MRG002 treatment.
- Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
- Patients with 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 :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04839510
Start Date
April 20 2021
End Date
September 1 2022
Last Update
December 14 2021
Active Locations (36)
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1
Anhui provincial Cancer Hospital
Hefei, Anhui, China, 230031
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
4
Beijing hospital
Beijing, Beijing Municipality, China, 100005