drugset / Trial / NCT06026501
A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor
Phase 1/2
Not yet recruiting
120 enrolled
Shanghai YingLi Pharmaceutical Co. Ltd.
Shanghai HyaMab Biotech Co.,Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.
Timeline
- Start
- 2023-08-31
- Primary completion
- 2027-08-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PE0105 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | PE0116 | Monoclonal antibody | 1 mg/kg | — |
| Subject | PE0116 | Monoclonal antibody | 2 mg/kg | — |