drugset / Trial / NCT05848466
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.
Timeline
- Start
- 2023-02-10
- Primary completion
- 2025-06-06
- Completion
- 2025-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT8010 | Unknown | 0.8 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 1.2 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 2.4 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 3.6 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 4.8 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 6 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 7.2 mg/kg | Intravenous |
| Subject | BAT8010 | Unknown | 8.4 mg/kg | Intravenous |
Indications
No indication recorded.