RecruitingPhase 2Phase 3NCT06879145

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

A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

840 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — SHR-A2102 (an antibody-drug conjugate) and adebrelimab (an immunotherapy drug) — given before surgery for people with muscle-invasive bladder cancer. The goal is to shrink the cancer before removing the bladder, and potentially improve survival. **You may be eligible if:** - You are 18 or older - You have been diagnosed with muscle-invasive bladder cancer that has not spread to distant organs - Your cancer has been confirmed by pathology and imaging - You are in good general health (ECOG score 0 or 1) - Your expected survival is at least 2 years - You have not received prior treatment for this cancer **You may NOT be eligible if:** - Your bladder cancer has spread to other organs (metastatic) - You have received previous chemotherapy, radiation, or immunotherapy for bladder cancer - You are pregnant - You have serious kidney, liver, or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A2102;Adebrelimab

Treatment with SHR-A2102 in combination with fixed dose Adebrelimab


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06879145