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R&d strategy adjustment
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To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS2543 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS2543 | Drug | Dose-escalation part For the dose-escalation study, five dose cohorts (25 mg , 75 mg , 150 mg , 300 mg , and 450 mg ) of HRS2543 are initially set. Dose-expansion part After the completion of dose-escalation study, the dose-expansion study will be carried out at the recommended dose level by the SMC. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 5.0 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle (28 days) will be considered a DLT by the investigator and SMC. | Day 1 to 28 (Cycle 1) |
| Maximum Tolerated Dose (MTD) | Toxicity will be evaluated according to the NCI CTCAE Version 5.0. | Day 1 to 28 (Cycle 1) |
| Recommended PhaseII Dose (RP2D) | Toxicity will be evaluated according to the NCI CTCAE Version 5.0. | Day 1 to 28 (Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with changes in laboratory measurements | up to 24 months | |
| Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG). | up to 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine, Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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HRS2543 monotherapy
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|
| Number of patients with changes in ECOG PS score. |
| up to 24 months |
| Number of patients with changes in Physical Examination. | up to 24 months |
| Number of patients with changes in Vital Signs | up to 24 months |
| Incidence of adverse events (AEs). | up to 24 months |
| Cmax of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| Tmax of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| AUC0-t of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| AUC0-∞ of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| t1/2 of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| Vz/F of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| CL/F of HRS2543 after single dose of HRS2543 | Day 1 of Cycle 1(each cycle 28 days) |
| Cmax,ss of HRS2543 after multiple dose administration of HRS2543 | Up to 4 cycles (each cycle 28 days) |
| Tmax,ss of HRS2543 after multiple dose administration of HRS2543 | Up to 4 cycles (each cycle 28 days) |
| Cmin,ss of HRS2543 after multiple dose administration of HRS2543 | Up to 4 cycles (each cycle 28 days) |
| AUCss of HRS2543 after multiple dose administration of HRS2543 | Up to 4 cycles (each cycle 28 days) |
| Rac of HRS2543 after multiple dose administration of HRS2543 | Up to 4 cycles (each cycle 28 days) |
| ORR: the Objective Response Rate | up to 24 months |
| DoR: the Duration of Response | up to 24 months |
| DCR: the Disease Control Rate | up to 24 months |
| PFS: the Progression Free Survival | up to 24 months |