Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 in participants with advanced solid tumors harboring RAS mutations or amplifications.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2329 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2329 Tablet | Drug | Oral HRS-2329 tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs). | Graded as per CTCAE v5.0. | From the screening period to 30 days after the last dose. |
| Incidence and severity of serious adverse events (SAEs). | Graded as per CTCAE v5.0. | From the screening period to 30 days after the last dose. |
| Dose-limiting toxicity (DLT). | From Day 1 to Day 21. | |
| Maximum tolerated dose (MTD). | From Day 1 to Day 21. | |
| Recommended Phase II Dose (RP2D). | 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax). | About 24 months. | |
| The time to maximum concentration (Tmax). | About 24 months. | |
| Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| About 24 months. |
| Area under concentration-time curve from time 0 to infinity (AUC 0-∞). | About 24 months. |
| Apparent volume of distribution (Vz/F). | About 24 months. |
| Elimination half-life (t1/2). | About 24 months. |
| Apparent clearance (CL/F). | About 24 months. |
| Minimum concentration at steady state (Cmin, ss). | About 24 months. |
| Area under the blood concentration-time curve at steady state (AUCss). | About 24 months. |
| Accumulation ratio (Rac). | About 24 months. |
| Objective response rate (ORR). | About 24 months. |
| Duration of response (DoR). | About 24 months. |
| Disease control rate (DCR). | About 24 months. |
| Progression-free survival (PFS). | About 24 months. |
| Overall survival (OS). | About 24 months. |