drugset / Trial / NCT07618260
SIM0613 in Participants With Advanced Solid Tumors
Phase 1
Recruiting
294 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Shanghai Xianwei Medical Technology Co., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2026-05-15
- Primary completion
- 2028-06
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIM0613 | Unknown | — | Intravenous |