drugset / Trial / NCT06985368
A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
NaSingle-groupOpen-labelTreatment
Summary
The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors
Timeline
- Start
- 2025-06-16
- Primary completion
- 2028-05-15
- Completion
- 2028-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIBP-A18 | Unknown | 1 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 2 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 3.2 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 4 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 4.8 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 5.6 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 6.4 mg/kg | Intravenous |
| Subject | SIBP-A18 | Unknown | 8 mg/kg | Intravenous |