9MW2821 and Toripalimab for Urothelial Cancer

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Recruiting Phase 3 Interventional Study
Urothelial Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
460 (estimated)
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for adults aged 18 to 80 with locally advanced or metastatic urothelial cancer who have not been treated before. Participants will receive a combination of two treatments and will need to follow study procedures.

Are You a Good Fit for This Trial?
Rules you out Active HBVActive HCVActive HIVSevere dry eyeActive keratitisCorneal ulcerSevere peripheral neuropathy

You may be able to join if

  • I am between 18 and 80 years old.
  • I have been diagnosed with locally advanced or metastatic urothelial cancer.
  • I have not received treatment for my cancer before.
  • I have at least one measurable tumor.
  • I am able to undergo cisplatin or carboplatin chemotherapy.
  • I expect to live for more than 12 weeks.
  • I can provide adequate tissue samples for testing.
  • I agree to use proper contraception during the study.

You may not be able to join if

  • I have had another cancer in the last 3 years.
  • I have an autoimmune disease that required treatment in the last 2 years.
  • I had significant heart or blood vessel problems in the last 6 months.
  • I have undergone major surgery or received certain treatments recently.
  • I have serious ongoing health issues or infections.
  • I have previously been treated with certain cancer therapies.
  • I have known allergies to any ingredients in the study drug.
  • I have a history of drug abuse or mental illness.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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…
Contacts

Dingwei Ye, Professor

13701663571

fuscc2012@163.com

CONTACT