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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with muscular invasive bladder cancer (MIBC), which is a type of bladder cancer that has spread into the muscle layer of the bladder. The researchers want to find out if a combination of two drugs, SHR-A2102 and Adebrelimab, is effective in treating this condition. This trial is in its second phase, meaning it’s looking at how well this new treatment works compared to the standard treatment, which includes gemcitabine and cisplatin, another combination of cancer-fighting medications.

To participate in this trial, patients need to be at least 18 years old and have been diagnosed with non-metastatic MIBC, meaning the cancer has not spread to other parts of the body. They should also have a good overall health status and be expected to survive for at least two more years. Participants will receive the study treatment and will be monitored for its effects. It’s important to note that those who have recently received other cancer treatments, have certain autoimmune diseases, or have serious health issues may not be eligible to join. The trial is not actively recruiting participants yet, but it represents an exciting opportunity for those looking for new treatment options for bladder cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age over 18 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