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)

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).

Study Overview

• Status: Recruiting
• Conditions: Muscular Invasive Bladder Cancer (MIBC)
• Intervention / Treatment: Drug: SHR-A2102；Adebrelimab

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoxue Pi; Phone Number: 0518-82342973; Email: Xiaoxue.pi@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Dingwei Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab	Drug: SHR-A2102；Adebrelimab; Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: SHR-A2102-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No