Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Conditions
Brief summary
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.
Interventions
DRUGHRS-7172 Tablets
HRS-7172 tablets.
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. ECOG performance status (PS) score of 0 or 1; 4. Life expectancy \> 3 months; 5. At least one measurable lesion per RECIST v1.1; 6. Adequate organ function.
Exclusion criteria
1. 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 |
|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | About 24 months. |
| Time to maximum concentration (Tmax) | About 24 months. |
| Objective response rate (ORR) | 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. |
| Elimination half-life (t1/2) | 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
Primary ContactRongfu Mao
Backup ContactJizhao Li
Outcome results
None listed