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Tests treatment safety and results for Bladder Cancer
Official title Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
ClinicalTrials.gov ID: NCT06551233
What this study is testing
What is 9MW2821?
9MW2821 is an investigational medicine, being studied as a potential treatment for bladder cancer.
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
- Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years old before signing the informed consent.
- people must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- people refuse or are intolerant to BCG therapy.
- people must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in...
- Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
You likely can't join if
- History of muscle invasive or metastatic bladder cancer.
- History of other malignancies within 3 years.
- Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
- Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to...
See the full eligibility criteria
- Age≥18 years old before signing the informed consent.
- people must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- people refuse or are intolerant to BCG therapy.
- people must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
- Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
- Histological and pathological diagnosis of urothelial carcinoma (with a major component \>50%) , with the confirmation of no-muscle invasion.
- people must be categorized as high-risk NMIBC
- people refuse or are intolerant to radical cystectomy.
- Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.
- Adequate function of heart, bone marrow, liver, and kidney.
- ECOG 0-1
- people must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).
- History of muscle invasive or metastatic bladder cancer.
- History of other malignancies within 3 years.
- Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
- Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.0.
- Active systemic infections that require treatments within 7 days before the first dose.
- Severe cardiovascular diseases within 6 months before the first dose.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of autoimmune diseases.
- Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.
- Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.
The study team makes the final eligibility decision.
Where it's taking place
- 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.