Tests 9MW2821 with toripalimab against chemotherapy for bladder-lining cancer
Compares 9MW2821 plus toripalimab with standard chemotherapy in adults with urothelial cancer.
Plain-language title generated from the registry record
Registry title: 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with urothelial cancer that has spread locally or to other parts of the body and has not been treated before.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Urothelial cancer confirmed by tissue tests, locally advanced or metastatic, with at least one measurable tumour. ECOG status 0 or 1.
- Earlier treatment
- No earlier treatment for locally advanced or metastatic urothelial cancer. No earlier PD-1, PD-L1, PD-L2 or CTLA-4 inhibitors. No earlier ADCs aimed at Nectin-4 or carrying the payload MMAE.
Main reasons for not taking part
- Another cancer within the last 3 years
- Autoimmune disease needing systemic treatment within the last 2 years
- Organ transplant or allogeneic stem cell transplant in the past
- Uncontrolled cancer in the central nervous system or carcinomatous meningitis
- Active HBV, HCV or HIV infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06592326, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT06592326
- Record updated
- 19 September 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: 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; Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment; 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; Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc; Any other serious chronic or uncontrolled disease; 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; Peripheral neuropathy Grade ≥ 2; Uncontrolled central nervous system metastases or carcinomatous meningitis.