Urothelial CarcinomaPhase 2NCT06823427
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2 study testing 9MW2821 and Toripalimab (JS001 ) in people with Urothelial Carcinoma and Urothelial Carcinoma Bladder, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 2 sites in China.
Trial summary
This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- What is being tested?
- 9MW2821 and Toripalimab (JS001 )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jan 2025to Jun 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation
- Age 18-80
- ECOG 0-1
- Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is >50%.
- Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma
- At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.
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- Life expectancy over 12 weeks
- Appropriate hematological and organ functions
- Agree to contraceptive measures until 180 days after the last dose of study drug administration
- Able to understand and follow study visits, treatment, laboratory assessment and other procedures
Who cannot join
- Other concurrent malignancy within 3 years prior to randomization
- Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (>10mg/day prednisolone equivalent) or other immunosuppressive agents.
- Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization
- Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
- Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.
- Have received prior treatment with anti-PD-1, anti-PD-L1/PD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.
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- Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.
- Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study
- Preexisting grade ≥ 2 neuropathy prior to randomization
- Other uncontrolled serious illness
- Brain metastasis or meningeal carcinomatosis
- HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive
- Known allergy to the study drug or components of the study drug
- Drug abuse or psychiatric disorder that would impact study compliance
- Other circumstances that the PI judges to be not suitable for the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hunan Tumor Hospital
Changsha, Hunan, 410013
Shusuan Jiang, +86-0731-88651900, jiangshusuan@hnca.org.cn
Shusuan Jiang
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Hongqian Guo, +86-025-83016666, gymwpi@126.com
Hongqian GUO
About this study
Official title: A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Being tested
- 9MW2821, Toripalimab (JS001 )
- Keywords
- 9MW2821
- 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
a nectin-4 ADC with MMAE payload
Toripalimab (JS001 )Drug
Also called toripalimab, JS001
anit-PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 9MW2821+toripalimab Receives: Drug: 9MW2821; Drug: Toripalimab (JS001 ) |
| Arm B | Active comparator | 9MW2821 monotherapy Receives: Drug: 9MW2821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate based on BICR
Measured: 3 yeras
Secondary outcomes (3)
Other efficacy endpoints
Overall survival; progression-free survival, duration of response, disease control rate, objective response rate based on investigator assessment and BICR
Measured: 3 years
Safety assessment
Incidences, severity and rates of treatment-emergent adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Incidence and rates serious adverse events. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record.
Measured: 3 years
Immunogenicity
Incidence, rates of ADA and NAb development. Titer of ADA and NAb.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start17 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06823427
- Sponsor's protocol ID
- 9MW2821-CP203
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06823427
- Acronym / sponsor ID
- 9MW2821-CP203
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Keywords
- 9MW2821
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Feb 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.
This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: 9MW2821, Drug: Toripalimab (JS001 )9MW2821+toripalimab |
| Arm B | Active comparator | Drug: 9MW28219MW2821 monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation
- Age 18-80
- ECOG 0-1
- Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is >50%.
- Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma
Key exclusion criteria (15 listed)
- Other concurrent malignancy within 3 years prior to randomization
- Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (>10mg/day prednisolone equivalent) or other immunosuppressive agents.
- Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization
- Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
- Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.
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 |
|---|---|---|
| 9MW2821a nectin-4 ADC with MMAE payload | Drug | Arm A, Arm B |
| Toripalimab (JS001 )Also: toripalimab, JS001anit-PD-1 antibody | Drug | Arm A |
Primary outcome
Objective Response Rate
Time frame: 3 yeras
Objective Response Rate based on BICR
3 secondary outcomes
Other efficacy endpoints
Time frame: 3 years
Safety assessment
Time frame: 3 years
Immunogenicity
Time frame: 3 years
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 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
2 sites 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 (JS001 ) in people with Urothelial Carcinoma and Urothelial Carcinoma Bladder, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 2 sites 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 15 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jia Wang (+8617356547673, jia.wang1@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 3 yeras). 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 21 Mar 2025.