Comparing two treatments for advanced urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a combination treatment of 9MW2821 and toripalimab against 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not previously received systemic therapy. Participants will be monitored for measurable tumor response according to established criteria. The trial aims to determine if the combination therapy offers improved outcomes compared to monotherapy in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* 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.
* 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

Where it's running

• Hunan Tumor Hospital
  Changsha, Hunan, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jia Wang
• Email: jia.wang1@mabwell.com
• Phone: +8617356547673

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

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• Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)

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• Combining 9MW2821 with toripalimab around surgery for urothelial cancer

  This trial tests whether giving 9MW2821 together with toripalimab before and after surgery helps adults with non-metastatic urothelial cancer.

  Recruiting Phase 2 Mabwell (Shanghai) Bioscience Co., Ltd. · Guangzhou, Guangdong · NCT07314723

• Trastuzumab Rezetecan with or without Adebrelimab for HER2-expressing advanced urothelial cancer

  This study will test whether Trastuzumab Rezetecan alone or combined with the immunotherapy Adebrelimab helps people with HER2-expressing locally advanced or metastatic urothelial cancer.

  Recruiting at 3 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 5 other locations · NCT07241793

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.