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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Muscular Invasive Bladder Cancer (MIBC)

Treatments: Drug: SHR-A2102；Adebrelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06879145

SHR-A2102-303

Details and patient eligibility

About

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).

Enrollment: 840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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840 participants in 1 patient group

Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab

Experimental group

Treatment:

Drug: SHR-A2102；Adebrelimab