Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D M
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.
| Condition(s) | Advanced KRAS G12D Mutant Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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, with no gender requirement; 3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received 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; A tumor tissue sample must be provided. 7. Adequate organ function Exclusion Criteria: 1. Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China |
| Start date | 2025-09-16 |
| NCT ID | NCT07134998 |
| Official listing | https://clinicaltrials.gov/study/NCT07134998 |