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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation and expansion | Experimental | Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821 | Drug | Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | assess the incidence of AE/SAE | up to 12 months |
| RP2D and MTD | Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DFS rate of 12 months | Disease-free survival rate of 12 months | Up to 12 months |
| DoR of CR | Duration of complete response | Up to 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo Hongqian, PhD | Contact | 8613605171690 | dr.ghq@nju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| CR rate of 3/6/12 months | Complete response rate of 3/6/12 months | Up to 12 months |
| DFS | Disease-free survival | Up to 20 months |
| Duration to radical cystectomy | Duration to radical cystectomy | Up to 20 months |
| Proportion of radical cystectomy | Proportion of radical cystectomy | Up to 20 months |
| Biomarker parameter | Expression of Nectin-4 | Up to 20 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |