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

Phase 2

Not yet recruiting

• Conditions: Muscular Invasive Bladder Cancer (MIBC)
• Interventions: Drug: SHR-A2102；Adebrelimab

• Registration Number: NCT06879145
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Start: 2025-05
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab	SHR-A2102；Adebrelimab	-

Primary Outcome Measures

Name	Time	Method
Phase II: pCR evaluated by researchers;	Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；	5 years after the first medication of the last subject

Secondary Outcome Measures

Name	Time	Method
ORR	from first dose to disease progression or death, whichever comes first, up to 3 years
DCR	from first dose to disease progression or death, whichever comes first, up to 3 years
pCR	Three months after MIBC surgery
EFS	from first dose to disease progression or death, whichever comes first, up to 3 years
DFS	from first dose to disease progression or death, whichever comes first, up to 3 years
OS	from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate	One month after the last subject underwent RC+PLD surgery
AE	from Day1 to 90 days after last dose

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China