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This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7058 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7058 capsule/ HRS-7058 tablet | Drug | HRS-7058 capsule/ HRS-7058 tablet |
|
| 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 | |
| Safety endpoints: adverse events (AE) | From the beginning of first patient in (FPI) to the end of study up to approximately 21 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion | From the beginning of first patient in (FPI) to the end of study up to approximately 21 months | |
| Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Zhang | Contact | +0518-81220121 | yifan.zhang.yz597@hengrui.com | |
| Keke Yan | Contact | +0518-81220121 | keke.yan@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| From the beginning of first patient in (FPI) to the end of study up to approximately 21 months |
| Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion | From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months |
| Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion | From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months |
| Efficacy endpoints: overall survival (OS) | From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months |