Muscular Invasive Bladder Cancer (MIBC)Phase 2/3NCT06879145
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
A Phase 2/3 study testing SHR-A2102；Adebrelimab in people with Muscular Invasive Bladder Cancer (MIBC), run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscular Invasive Bladder Cancer (MIBC)
- What is being tested?
- SHR-A2102；Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to Dec 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye
About this study
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)
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)
- Being tested
- SHR-A2102；Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102；AdebrelimabDrug
Treatment with SHR-A2102 in combination with fixed dose Adebrelimab
| Study group | Role | What they receive |
|---|---|---|
| Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab | Experimental | Not described Receives: Drug: SHR-A2102；Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: pCR evaluated by researchers;
Measured: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；
Measured: 5 years after the first medication of the last subject
Secondary outcomes (8)
ORR
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
DCR
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
pCR
Measured: Three months after MIBC surgery
EFS
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
DFS
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
OS
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate
Measured: One month after the last subject underwent RC+PLD surgery
AE
Measured: from Day1 to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start25 Apr 2025
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879145
- Sponsor's protocol ID
- SHR-A2102-303
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06879145
- Acronym / sponsor ID
- SHR-A2102-303
- Conditions
- Muscular Invasive Bladder Cancer (MIBC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab | Experimental | Drug: SHR-A2102；Adebrelimab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A2102；AdebrelimabTreatment with SHR-A2102 in combination with fixed dose Adebrelimab | Drug | Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab |
Primary outcome
Phase II: pCR evaluated by researchers;
Time frame: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；
Time frame: 5 years after the first medication of the last subject
8 secondary outcomes
ORR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DCR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
pCR
Time frame: Three months after MIBC surgery
EFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
OS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate
Time frame: One month after the last subject underwent RC+PLD surgery
AE
Time frame: from Day1 to 90 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Muscular Invasive Bladder Cancer (MIBC)
Active, not recruitingPhase 1/2
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
RecruitingPhase 2
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
Bladder Cancer, Urothelial Carcinoma
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 2
Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC
Bladder Cancer
Active, not recruitingPhase 2
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR-A2102；Adebrelimab in people with Muscular Invasive Bladder Cancer (MIBC), run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxue Pi (0518-82342973, xiaoxue.pi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: pCR evaluated by researchers; (time frame: Three months after the last subject underwent RC+PLD surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.