Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China
Summary
the main purpose: * Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability * Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules. Secondary purpose: * Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug; * Evaluate the immunogenicity of BAT6026 injection; * Evaluate the pharmacodynamic properties of BAT6026 injection; * Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.
Timeline
- Start
- 2021-12-23
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT6026 | Monoclonal antibody | 0.01 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 0.03 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | BAT6026 | Monoclonal antibody | 10 mg/kg | Intravenous |