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

NCT06879145 | Recruiting Phase 2

• 1 other identifier: SHR-A2102-303
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscular Invasive Bladder Cancer (MIBC)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (1)

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

EXPERIMENTAL

Drug: SHR-A2102；Adebrelimab

Interventions

SHR-A2102；Adebrelimab DRUG

Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.18-80 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

You may not qualify if:

• Received systemic anti-tumor therapy 4 weeks before starting the study treatment
• The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
• Subjects known or suspected to have interstitial pneumonia
• Individuals with any active, known or suspected autoimmune diseases
• There are clinical symptoms or diseases of the heart that have not been well controlled
• Diagnosed with any other malignant tumor
• Subjects who have experienced severe infections within 28 days prior to their first medication use
• History of immunodeficiency
• Use of attenuated live vaccine within 28 days prior to the first study medication
• Have undergone major surgery within 28 days prior to the first administration of medication

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Xiaoxue Pi

CONTACT

0518-82342973; xiaoxue.pi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CN (1)