Clinical trial NCT06879145: Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Muscular Invasive Bladder Cancer (MIBC)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Phase II: pCR evaluated by researchers;
timeFrame: Three months after the last subject underwent RC+PLD surgery
measure: Phase III: EFS assessed by BICR；
timeFrame: 5 years after the first medication of the last subject
Secondary outcomes:
measure: ORR
timeFrame: from first dose to disease progression or death, whichever comes first, up to 3 years
measure: DCR
timeFrame: from first dose to disease progression or death, whichever comes first, up to 3 years
measure: pCR
timeFrame: Three months after MIBC surgery
measure: EFS
timeFrame: from first dose to disease progression or death, whichever comes first, up to 3 years
measure: DFS
timeFrame: from first dose to disease progression or death, whichever comes first, up to 3 years
measure: OS
timeFrame: from first dose to disease progression or death, whichever comes first, up to 3 years
measure: R0 resection rate
timeFrame: One month after the last subject underwent RC+PLD surgery
measure: AE
timeFrame: from Day1 to 90 days after last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: