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This is a phase I study of HRS-7172 to evaluate safety, tolerability and pharmacokinetics in participants with advanced solid tumors harboring RAS mutations or amplifications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7172 Group | Experimental | Oral HRS-7172. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7172 Tablets | Drug | HRS-7172 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | From screening period up to 30 days after the last dose. | |
| Incidence and severity of serious adverse events (SAEs) | From screening period up to 30 days after the last dose. | |
| Dose-limiting toxicity (DLT) | From day 1 to day 24. | |
| Maximum tolerated dose (MTD) | From day 1 to day 24. | |
| Recommended Phase II Dose (RP2D) | From day 1 to day 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | About 24 months. | |
| Duration of response (DoR) | About 24 months. | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongfu Mao | Contact | +86-021-61053363 | rongfu.mao@hengrui.com | |
| Jizhao Li | Contact | +86-021-61053363 | jizhao.li.jl565@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| About 24 months. |
| Progression-free survival (PFS) | About 24 months. |
| Overall survival (OS) | About 24 months. |
| Maximum plasma concentration (Cmax) | About 24 months. |
| Time to maximum concentration (Tmax) | About 24 months. |
| Elimination half-life (t1/2) | About 24 months. |
| Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t) | About 24 months. |
| Area under concentration-time curve from time 0 to infinity (AUC0-∞) | About 24 months. |