A Phase 2/3 interventional study of SHR-A2102；Adebrelimab in Muscular Invasive Bladder Cancer (MIBC), sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 2/3, Interventional, and Treatment
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).
Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- 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
Exclusion Criteria:
Drug: SHR-A2102；Adebrelimab
Treatment with SHR-A2102 in combination with fixed dose Adebrelimab
Phase II: pCR evaluated by researchers;
Time frame: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；
Time frame: 5 years after the first medication of the last subject
ORR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DCR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
pCR
Time frame: Three months after MIBC surgery
EFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
OS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate
Time frame: One month after the last subject underwent RC+PLD surgery
AE
Time frame: from Day1 to 90 days after last dose
Plan to share: Undecided
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.