9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Recruiting
Phase 3Interventional 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.
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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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City
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Status
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…
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.
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