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This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Group | Experimental | SHR-4610 dose A in dose escalation stage. |
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| Cohort 2 Group | Experimental | SHR-4610 dose B in dose escalation stage. |
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| Cohort 3 Group | Experimental | SHR-4610 dose C in dose escalation stage. |
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| Cohort 4 Group | Experimental | SHR-4610 dose D in dose escalation stage. |
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| Cohort 5 Group | Experimental | SHR-4610 dose A/B/C/D in dose expansion stage. |
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| Cohort 6 Group | Experimental | SHR-4610 dose A/B/C/D in efficacy expansion stage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4610 Injection | Drug | SHR-4610 injection in different dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Dose-Limiting Toxicity (DLT) | Post-dose at day 1 to the end of treatment visit, about 1 year. | |
| The Maximum Tolerated Dose (MTD) | Post-dose at day 1 to the end of treatment visit, about 1 year. | |
| Recommended dosage for Phase II (RP2D) | Post-dose at day 1 to the end of treatment visit, about 1 year. | |
| Incidence and severity of adverse events (AEs) | Up to 90 days after the last administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | From the first administration to the end of treatment visit, about 1 year. | |
| Duration of relief (DOR) | From the first administration to the end of treatment visit, about 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Jin | Contact | +86-021-61053363 | yunpeng.jin.yj1@hengrui.com | |
| Yuting Wang | Contact | +86-021-61053363 | yuting.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| Disease Control Rate (DCR) | From the first administration to the end of treatment visit, about 1 year. |
| Time to Response (TTR) | From the first administration to the end of treatment visit, about 1 year. |
| Progression-free survival (PFS) | From the first administration to the end of treatment visit, about 1 year. |
| Time to the maximum plasma concentration (Tmax) | From Day 1 pre-dose to 30 days after the last administration. |
| Maximum concentration of SHR-4610 (Cmax) | From Day 1 pre-dose to 30 days after the last administration. |
| SHR-4610 serum trough concentration (Ctrough) | From Day 1 pre-dose to 30 days after the last administration. |
| Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t) | From Day 1 pre-dose to 30 days after the last administration. |