NCT06551233 Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
| NCT ID | NCT06551233 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-04-22 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age≥18 years old before signing the informed consent. * Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc. * Subjects refuse or are intolerant to BCG therapy. * Subjects 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. * Subjects must be categorized as high-risk NMIBC * Subjects 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 * Subjects 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). Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06551233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06551233 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06551233 currently recruiting?
Yes, NCT06551233 is actively recruiting participants. Contact the research team at dr.ghq@nju.edu.cn for enrollment information.
Where is the NCT06551233 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06551233 clinical trial?
NCT06551233 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 30 participants.
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