Urothelial CarcinomaPhase 3NCT06592326
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
A Phase 3 study testing 9MW2821, Toripalimab and Gemcitabine in people with Urothelial Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- 9MW2821, Toripalimab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2024to Dec 2028
- Phase
- Phase 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
- Sign the informed consent form approved by IEC.
- Male or female subjects aged 18 to 80 years.
- ECOG status: 0 or 1.
- Histologically confirmed local advanced or metastatic urothelial cancer
- Previously untreated with local advanced or metastatic urothelial cancer
- At least one measurable lesion, according to RECIST V1.1.
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- Adequate tumor tissues submitted for test
- Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator
- Life expectancy for more than 12 weeks.
- Adequate organ functions.
- Proper contraception methods.
- Willingness to follow the study procedures.
Who cannot join
- 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 6 months.
- Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
- Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
- Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
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- Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
- Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
- Peripheral neuropathy Grade ≥ 2.
- Any other serious chronic or uncontrolled disease.
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
- Active HBV/HCV/HIV infection, etc.
- 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye, Professor, 13701663571, fuscc2012@163.com
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer
This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.
Read the detailed description
The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.
- Conditions
- Urothelial Carcinoma
- Being tested
- 9MW2821, Toripalimab, Gemcitabine, Cisplatin/Carboplatin
- 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
ToripalimabDrug
Also called Toripalimab injection
Toripalimab, 240mg, intravenous (IV) infusion
GemcitabineDrug
Also called Gemcitabine Hydrochloride for Injection
Gemcitabine: 1000mg/m2, intravenous (IV) infusion
Cisplatin/CarboplatinDrug
Also called Cisplatin for injection/Carboplatin Injection
Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| 9MW2821+Toripalimab | Experimental | 9MW2821+Toripalimab Receives: Drug: 9MW2821; Drug: Toripalimab |
| Gemcitabine+Cisplatin/Carboplatin | Active comparator | Gemcitabine+Cisplatin/Carboplatin Receives: Drug: Gemcitabine; Drug: Cisplatin/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
BICR-PFS
Progression-free survival, assessed by BICR
Measured: up to 50 months
OS
Overall Survival
Measured: up to 50 months
Secondary outcomes (6)
ORR
Objective response rate, assessed by BICR or investigator
Measured: Up to 50 months
DCR
Disease control rate, assessed by BICR or investigator
Measured: Up to 50 months
DoR
Duration of response, assessed by BICR or investigator
Measured: Up to 50 months
PFS
Progression-free survival, assessed by investigator
Measured: Up to 50 months
AE/SAE
Adverse event, serious adverse event
Measured: Up to 50 months
Immunogenicity
Anti-Drug Antibody (ADA) of 9MW2821
Measured: Up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Aug 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 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
- NCT06592326
- Sponsor's protocol ID
- 9MW2821-CP302
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25.
PubMed 40288679
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06592326
- Acronym / sponsor ID
- 9MW2821-CP302
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (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 randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.
Detailed description
The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9MW2821+Toripalimab | Experimental | Drug: 9MW2821, Drug: Toripalimab9MW2821+Toripalimab |
| Gemcitabine+Cisplatin/Carboplatin | Active comparator | Drug: Gemcitabine, Drug: Cisplatin/CarboplatinGemcitabine+Cisplatin/Carboplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign the informed consent form approved by IEC.
- Male or female subjects aged 18 to 80 years.
- ECOG status: 0 or 1.
- Histologically confirmed local advanced or metastatic urothelial cancer
- Previously untreated with local advanced or metastatic urothelial cancer
Key exclusion criteria (15 listed)
- 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 6 months.
- Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
- Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
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 | 9MW2821+Toripalimab |
| ToripalimabAlso: Toripalimab injectionToripalimab, 240mg, intravenous (IV) infusion | Drug | 9MW2821+Toripalimab |
| GemcitabineAlso: Gemcitabine Hydrochloride for InjectionGemcitabine: 1000mg/m2, intravenous (IV) infusion | Drug | Gemcitabine+Cisplatin/Carboplatin |
| Cisplatin/CarboplatinAlso: Cisplatin for injection/Carboplatin InjectionCisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion. | Drug | Gemcitabine+Cisplatin/Carboplatin |
Primary outcome
BICR-PFS
Time frame: up to 50 months
Progression-free survival, assessed by BICR
OS
Time frame: up to 50 months
Overall Survival
6 secondary outcomes
ORR
Time frame: Up to 50 months
DCR
Time frame: Up to 50 months
DoR
Time frame: Up to 50 months
PFS
Time frame: Up to 50 months
AE/SAE
Time frame: Up to 50 months
Immunogenicity
Time frame: Up to 50 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 19 Sep 2024.
- Derived from this study: PubMed 40288679Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25.
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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 3 study testing 9MW2821, Toripalimab and Gemcitabine 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 12 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 19 Sep 2024. 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 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 Dingwei Ye, Professor (13701663571, fuscc2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BICR-PFS (time frame: up to 50 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?
On the ClinicalTrials.gov record for NCT06592326, which also lists 1 linked publication.
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 19 Sep 2024.