Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Recruiting now · Phase 2/Phase 3
Conditions studied: Muscular Invasive Bladder Cancer (MIBC)
In brief
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 evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).
Key facts
- Study ID
- NCT06879145
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 840
- Starts
- 2025-04-25
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function
You may not qualify if…
- 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
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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