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Compares treatment options for Urothelial Carcinoma
Official title 9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
ClinicalTrials.gov ID: NCT06823427
What this study is testing
What is 9MW2821?
9MW2821 is an investigational medicine, being studied as a potential treatment for urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma
You likely can't join if
- 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...
- 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...
- Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord...
- 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...
See the full eligibility 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.