NCT06592326 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
| NCT ID | NCT06592326 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2024-08-22 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 460 participants in total. It began in 2024-08-22 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06592326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06592326 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 460 participants.
Is NCT06592326 currently recruiting?
Yes, NCT06592326 is actively recruiting participants. Contact the research team at fuscc2012@163.com for enrollment information.
Where is the NCT06592326 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06592326 clinical trial?
NCT06592326 is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. The trial plans to enroll 460 participants.