drugset / Trial / NCT05145179
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2023-12-01
- Completion
- 2024-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SSGJ-705 | Unknown | 0.1 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 1 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 3 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 6 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 10 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 15 mg/kg | Intravenous |
| Subject | SSGJ-705 | Unknown | 20 mg/kg | Intravenous |
Indications
No indication recorded.