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Clinical Trials in China / NCT06879145
Recruiting Phase 2/3

Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

NCT06879145 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 2/3
Started
2025-04-25
Last updated
2026-07-13

Condition(s) studied

Muscular Invasive Bladder Cancer (MIBC)

Investigational drug(s) / intervention(s)

SHR-A2102;Adebrelimab

SHR-A2102;Adebrelimab: Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

Study 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: \- 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: 1. Received systemic anti-tumor therapy 4 weeks before starting the study treatment 2. The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level 3. Subjects known or suspected to have interstitial pneumonia 4. Individuals with any active, known or suspected autoimmune diseases 5. There are clinical symptoms or diseases of the heart that have not been well controlled 6. Diagnosed with any other malignant tumor 7. Subjects who have experienced severe infections within 28 days prior to their first medication use 8. History of immunodeficiency 9. Use of attenuated live vaccine within 28 days prior to the first study medication 10. Have undergone major surgery within 28 days prior to the first administration of medication

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06879145 on ClinicalTrials.gov ↗ ← All trials in China