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This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6093 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6093 | Drug | HRS-6093 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0). | Screening Period to 30 Days After the Last Dose | |
| DLT, | from day1 to day 23; 23 Days | |
| MTD, | from day1 to day 23; 23 Days | |
| RP2D , | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | Screening Period to 30 Days After the Last Dose; 24 months | |
| Number of subjects with clinically significant changes in ECOG, vital signs and physical examination. | Screening Period to 30 Days After the Last Dose; 24 months |
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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 |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Number of subjects with changes on ECG. | Screening Period to 30 Days After the Last Dose; 24 months |
| maximum plasma concentration (Cmax), | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| time to maximum concentration (Tmax), | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t), | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| Area under concentration-time curve from time 0 to infinity (AUC 0-∞), apparent volume of distribution (Vz/F), | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| elimination half-life (t1/2), and apparent clearance (CL/F); | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| minimum concentration at steady state (Cmin, ss), | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| area under the blood concentration-time curve at steady state (AUCss), and accumulation ratio (Rac); | Screening Period to Day of the end of treatment/withdrawal. 24 months |
| objective response rate (ORR), | Screening Period to PD; 24 months |
| duration of response (DoR), | Screening Period to PD; 24 months |
| disease control rate (DCR), | Screening Period to PD; 24 months |
| progression-free survival (PFS), | Screening Period to PD; 24 months |
| overall survival (OS). | Screening Period to Day of death of the participant;24months |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|