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A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
Details
| Lead sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 232 |
| Start date | 2025-11-07 |
| Completion | 2029-06 |
Conditions
- Advanced Solid Cancer
Interventions
- SIM0609 for injection
- dose expansion of SIM0609 in CRC
- dose expansion of SIM0609 in GC/GEJC cohort
- dose expansion of SIM0609 in PDAC cohort
- dose expansion of SIM0609 in positive other solid tumors
Primary outcomes
- Dose escalation:Dose -limiting toxicity (DLT) — At the end of Cycle 1 (each cycle is 21/28days)
- Dose escalation:Safety and Tolerability — 2 years
Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity - Dose escalation: Objective response rate(ORR) — 2 years
Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 1.1
Countries
China