Actively Recruiting
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
Led by Shanghai Miracogen Inc. · Updated on 2023-04-13
290
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
CONDITIONS
Official Title
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and follow the protocol requirements
- Aged 18 to 75 years, any gender
- Expected survival time of at least 12 weeks
- Diagnosed with unresectable locally advanced or metastatic urothelial cancer confirmed by histopathology
- Previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors and have progressive disease or recurrence
- Able to provide archival or biopsy tumor specimens
- HER2 positive in tumor specimens confirmed by central lab (IHC 3+ or 2+)
- Must have measurable lesions according to RECIST v1.1
- ECOG performance status of 0 or 1
- Prior anti-tumor treatment-related adverse events recovered to Grade 1 or less (except alopecia, Grade 2 hypothyroidism, or non-clinically significant lab abnormalities)
- Organ function meets basic requirements
- Patients of childbearing potential must use effective contraception during treatment and for 180 days after last dose
You will not qualify if you...
- History of hypersensitivity to MRG002 components or Grade 3 or higher hypersensitivity to trastuzumab
- Prior treatment with ADC drugs, taxane, gemcitabine, or pemetrexed for advanced urothelial cancer
- Received investigational drugs, chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks before first dose
- Received herbal or Chinese patent medicine with anti-tumor effects within 2 weeks before first dose
- Use or need of strong CYP3A4 inhibitors within 2 weeks before first dose or currently required
- Major surgery within 4 weeks before first dose without full recovery or planned surgery within 12 weeks after study treatment
- Symptoms requiring puncture drainage of pleural, abdominal, or pericardial effusion
- Central nervous system metastasis or neoplastic meningitis
- Severe or uncontrolled systemic diseases
- Poorly controlled heart disease
- Active infections including Hepatitis B, Hepatitis C, or HIV
- History of other primary cancers
- History of interstitial pneumonia, severe COPD, pulmonary insufficiency, or symptomatic bronchospasm
- Peripheral neuropathy greater than Grade 1
- History of cirrhosis
- Active autoimmune disease or history requiring immunosuppressive agents or systemic hormone therapy within 2 weeks prior to enrollment
- Uncontrolled tumor-associated bone pain or urgent spinal cord compression
- Other conditions making participation inappropriate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
P
Program Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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