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This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2005 | Experimental | Only one arm with SHR-2005 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2005 | Drug | In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | From Day 1 to Day 21 | |
| Maximum tolerated dose (MTD) | From Day 1 to Day 21 | |
| Incidence and severity of adverse events (AEs) ([CTCAE] v5.0) | From Day 1 to 90 days after last dose | |
| RP2D(Recommended Phase 2 dose) | From Day 1 to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Tmax of SHR-2005 | Time to maximum concentration of SHR-2005 | approximately 24 months |
| PK parameter: Cmax of SHR-2005 | Maximum concentration of SHR-2005 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shouwei Zhao | Contact | 0518-82342973 | shouwei.zhao@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
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| approximately 24 months |
| PK parameter: AUC0-∞ of SHR-2005 | area under the concentration-time curve from time 0 to infinity of SHR-2005 | approximately 24 months |
| Immunogenicity of SHR-2005 | Anti- SHR-2005 antibody (ADA) | approximately 24 months |
| Duration of response (DoR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Disease control rate (DCR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Progression-free survival (PFS) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Amount_recovered and Percent_recovered | The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation. | approximately 24 months |