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This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS7415 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS7415 | Drug | Drug: HRS7415 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months | |
| maximum tolerated dose (MTD) | From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months | |
| Phase II recommended dose (RP2D) | From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, duration, and association of adverse events (AE) and severe adverse events (SAE) with the study drug, in addition to abnormalities in vital signs, electrocardiogram, and laboratory tests | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years | |
| Single dose parameters: Peak plasma concentration (Cmax) of HRS7415 and its main metabolite after single dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250021 | China |
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The study was divided into two phases, the dose escalation phase and the dose extension phase of HRS7415 in subjects with advanced malignant tumors.
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| From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Single dose parameters: Time to peak (Tmax) of HRS7415 and its main metabolite after single dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 year |
| Single dose parameters: Area under the curve from 0 to the last measurable concentration time point t (AUC0-t) of HRS7415 and its main metabolite after single dosing (if applicable) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Single dose parameters: Area under the time curve from 0 to infinity (AUC0-inf) of HRS7415 and its main metabolite after single dosing (if applicable) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Single dose parameters: Half-value period (t1/2) of HRS7415 and its main metabolite after single dosing (if applicable) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Single dose parameters: Apparent volume of distribution (Vz/F) of HRS7415 and its main metabolite after single dosing (if applicable) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Single dose parameters: Apparent clearance (CL/F) of HRS7415 and its main metabolite after single dosing (if applicable) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Multiple dose parameters: Steady state peak concentration (Cmax,ss) of HRS7415 and its main metabolite after multiple dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Multiple dose parameters: Time to peak (Tmax, ss) of HRS7415 and its main metabolite after multiple dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Multiple dose parameters: Steady valley concentration (Cmin,ss) of HRS7415 and its main metabolite after multiple dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Multiple dose parameters: Area under steady-state drug concentration-time curve (AUCss) of HRS7415 and its main metabolite after multiple dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Multiple dose parameters: Drug storage ratio (Rac) of HRS7415 and its main metabolite after multiple dosing | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Efficacy endpoints: Objective response rate (ORR) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Efficacy endpoints: Disease control rate (DCR) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Efficacy endpoints: Duration of response (DoR) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |
| Efficacy endpoints: Progression-free survival (PFS) | From the beginning of first patient in (FPI) to the end of study up to approximately 2 years |