SIM0613 in Participants With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion p
| Condition(s) | Advanced Solid Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2). |
| Who can participate | Inclusion Criteria: 1. Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study 2. ≥18 years of age 3. Histologically or cytologically confirmed locally advanced/metastatic solid tumors 4. Have at least one measurable disease per RECIST Version 1.1 criteria 5. Have experienced disease progression on/after at least one accessible standard therapy, or are intolerant to standard therapy, or are not suitable for standard therapy, or for whom clinical trial of the investigational drug serves as standard treatment 6. Life expectancy of ≥12 weeks 7. Have adequate organ function 8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the start of study treatment. 9. For Part 1, archival or fresh t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
| Locations | Tianjin, Tianjin Municipality, China |
| Start date | 2026-05-15 |
| NCT ID | NCT07618260 |
| Official listing | https://clinicaltrials.gov/study/NCT07618260 |