Urothelial CarcinomaPhase 2NCT07314723
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
A Phase 2 study testing 9MW2821 and Toripalimab Injection in people with Urothelial Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- 9MW2821 and Toripalimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form approved by IEC.
- Male or female subjects aged ≥18 years old.
- ECOG status: 0 or 1.
- Histologically confirmed urothelial cancer.
- Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.
- Adequate tumor tissues submitted for test.
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- Life expectancy for more than 12 weeks.
- Adequate organ functions.
- Proper contraception methods.
- Willingness to follow the study procedures.
Who cannot join
- Prior systemic anti-tumor therapy for urothelial cancer.
- Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- History of another malignancy within 3 years.
- History of autoimmune disease requiring systemic treatment within 2 years.
- History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 1 year.
- Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days.
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- Peripheral neuropathy Grade ≥ 2.
- Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
- Active HBV/HCV/HIV infection, etc.
- Any other serious chronic or uncontrolled disease.
- Any live vaccines got within 28 days.
- Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- Any potent CYP3A4 inducers/inhibitors taken within 14 days.
- Known allergic sensitivity to any of the ingredients of the study drug.
- History of drug abuse or mental illness.
- Other conditions unsuitable into the study.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhuowei Liu, Professor, 86-20-87343606, liuzhw@sysucc.org.cn
About this study
Official title: A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
- Conditions
- Urothelial Carcinoma
- Being tested
- 9MW2821, Toripalimab Injection
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab InjectionDrug
Toripalimab, 240mg, intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MIBC | Experimental | Not described Receives: Drug: 9MW2821; Drug: Toripalimab Injection |
| Arm 2: High-risk UTUC | Experimental | Not described Receives: Drug: 9MW2821; Drug: Toripalimab Injection |
| Arm 3: MIBC | Experimental | Not described Receives: Drug: 9MW2821; Drug: Toripalimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR (Arm 1 and 2)
Pathological complete response
Measured: Up to 24 months
cCR (Arm 3)
Clinical complete response
Measured: Up to 24 months
Secondary outcomes (9)
cORR
Clinical objective response rate
Measured: Up to 24 months
Pathological downstaging rate (Arm 1 and 2)
Measured: Up to 24 months
DFS (Arm 1 and 2)
Disease-free survival
Measured: Up to 24 months
Duration of clinical complete response (Arm 3)
Measured: Up to 24 months
PFS (Arm 3)
Progression-free survival
Measured: Up to 24 months
OS
Overall Survival
Measured: Up to 24 months
AE/SAE
Adverse event, serious adverse event
Measured: Up to 24 months
Immunogenicity
Anti-Drug Antibody (ADA) of 9MW2821
Measured: Up to 24 months
Nectin-4 and PD-L1 expression
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314723
- Sponsor's protocol ID
- 9MW2821-CP202
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
- ClinicalTrials.gov ID
- NCT07314723
- Acronym / sponsor ID
- 9MW2821-CP202
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (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.
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MIBC | Experimental | Drug: 9MW2821, Drug: Toripalimab Injection |
| Arm 2: High-risk UTUC | Experimental | Drug: 9MW2821, Drug: Toripalimab Injection |
| Arm 3: MIBC | Experimental | Drug: 9MW2821, Drug: Toripalimab Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign the informed consent form approved by IEC.
- Male or female subjects aged ≥18 years old.
- ECOG status: 0 or 1.
- Histologically confirmed urothelial cancer.
- Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.
Key exclusion criteria (16 listed)
- Prior systemic anti-tumor therapy for urothelial cancer.
- Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- History of another malignancy within 3 years.
- History of autoimmune disease requiring systemic treatment within 2 years.
- History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 1 year.
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 |
|---|---|---|
| 9MW28219MW2821, 1.25mg/kg, intravenous (IV) infusion | Drug | Arm 1: MIBC, Arm 2: High-risk UTUC, Arm 3: MIBC |
| Toripalimab InjectionToripalimab, 240mg, intravenous (IV) infusion | Drug | Arm 1: MIBC, Arm 2: High-risk UTUC, Arm 3: MIBC |
Primary outcome
pCR (Arm 1 and 2)
Time frame: Up to 24 months
Pathological complete response
cCR (Arm 3)
Time frame: Up to 24 months
Clinical complete response
9 secondary outcomes
cORR
Time frame: Up to 24 months
Pathological downstaging rate (Arm 1 and 2)
Time frame: Up to 24 months
DFS (Arm 1 and 2)
Time frame: Up to 24 months
Duration of clinical complete response (Arm 3)
Time frame: Up to 24 months
PFS (Arm 3)
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
AE/SAE
Time frame: Up to 24 months
Immunogenicity
Time frame: Up to 24 months
Nectin-4 and PD-L1 expression
Time frame: Up to 24 months
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 2 Jan 2026.
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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 study testing 9MW2821 and Toripalimab Injection in people with Urothelial Carcinoma, run by Mabwell (Shanghai) Bioscience 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 10 inclusion and 16 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 2 Jan 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 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.
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 Zhuowei Liu, Professor (86-20-87343606, liuzhw@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (Arm 1 and 2) (time frame: Up to 24 months). 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 2 Jan 2026.