Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Conditions
Brief summary
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.
Interventions
DRUGHRS-2329 Tablet
Oral HRS-2329 tablet.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up; 2. Aged between 18-75 years old; 3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed standard treatment; 4. ECOG performance status (PS) score of 0 or 1; 5. Life expectancy \> 3 months; 6. At least one measurable lesion per RECIST v1.1; 7. Adequate organ function.
Exclusion criteria
1. Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs). | From the screening period to 30 days after the last dose. | Graded as per CTCAE v5.0. |
| Incidence and severity of serious adverse events (SAEs). | From the screening period to 30 days after the last dose. | Graded as per CTCAE v5.0. |
| 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. | — |
Secondary
| Measure | 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). | 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. |
Countries
China
Contacts
CONTACTRongfu Mao
CONTACTJizhao Li
Outcome results
None listed