drugset / Trial / NCT05203601
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of • To evaluate the safety, tolerability and pharmacokinetic characteristics of SIBP-03（Recombinant anti-HER3 humanized monoclonal antibody injection）. A secondary purpose * Assess the immunogenicity of SIBP-03. Exploratory purpose * Explore potential biomarkers; * Preliminary evaluation of the antitumor efficacy of SIBP-03.
Timeline
- Start
- 2020-11-26
- Primary completion
- 2022-12-06
- Completion
- 2022-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIBP-03 | Monoclonal antibody | 2 mg/kg | — |
| Subject | SIBP-03 | Monoclonal antibody | 5 mg/kg | — |
| Subject | SIBP-03 | Monoclonal antibody | 10 mg/kg | — |
| Subject | SIBP-03 | Monoclonal antibody | 15 mg/kg | — |
| Subject | SIBP-03 | Monoclonal antibody | 20 mg/kg | — |
| Subject | SIBP-03 | Monoclonal antibody | 40 mg/kg | — |