SHR-A2102 plus adebrelimab for muscle-invasive bladder cancer

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)

This study tests whether injections of SHR-A2102 combined with adebrelimab help adults with non-metastatic muscle-invasive bladder cancer and in phase III compares the combo to standard gemcitabine plus cisplatin chemotherapy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 840 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: Adebrelimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06879145 on ClinicalTrials.gov

What this trial studies

This interventional program gives adults with non-metastatic muscle-invasive bladder cancer injections of SHR-A2102 together with the PD-L1 antibody adebrelimab (SHR-1316). Phase II focuses on the combination's tumor response and safety in patients with measurable disease by RECIST 1.1 while requiring ECOG 0–1 and adequate organ function. Phase III randomly assigns patients to receive the SHR-A2102 plus adebrelimab combination or standard gemcitabine plus cisplatin to compare efficacy and safety outcomes. Participants are followed for tumor response, progression, and treatment-related adverse events.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed non-metastatic muscle-invasive bladder cancer who have measurable lesions by RECIST 1.1, ECOG performance status 0–1, adequate organ function, and who can give informed consent are the intended candidates.

Not a fit: Patients with metastatic disease, active autoimmune disease or interstitial pneumonia, uncontrolled cardiac conditions, recent severe infections, immunodeficiency, other active malignancies, or recent systemic anti-cancer therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combination could improve tumor control and survival outcomes and offer an alternative or complement to standard chemotherapy for muscle-invasive bladder cancer.

How similar studies have performed: Checkpoint inhibitors (PD-1/PD-L1) and various targeted or local agents have shown activity in bladder cancer, but the SHR-A2102 plus adebrelimab combination is a novel pairing with limited prior clinical data.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoxue Pi

Conditions: Muscular Invasive Bladder Cancer