Status:
RECRUITING
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Muscular Invasive Bladder Cancer (MIBC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to ev...
Eligibility Criteria
Inclusion
- Age over 18 years old, gender not limited.
- The patient voluntarily joined this study and signed informed consent
- ECOG score is 0 or 1
- Expected survival period ≥ 2 years.
- Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer
- There are assessable lesions that meet the RECIST 1.1 criteria
- Enough organ function
Exclusion
- Received systemic anti-tumor therapy 4 weeks before starting the study treatment
- The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
- Subjects known or suspected to have interstitial pneumonia
- Individuals with any active, known or suspected autoimmune diseases
- There are clinical symptoms or diseases of the heart that have not been well controlled
- Diagnosed with any other malignant tumor
- Subjects who have experienced severe infections within 28 days prior to their first medication use
- History of immunodeficiency
- Use of attenuated live vaccine within 28 days prior to the first study medication
- Have undergone major surgery within 28 days prior to the first administration of medication
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06879145
Start Date
April 25 2025
End Date
December 1 2031
Last Update
June 18 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032