drugset / Trial / NCT05102214
HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX301 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion.
Timeline
- Start
- 2022-05-03
- Primary completion
- 2023-09-15
- Completion
- 2024-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HLX301 | Unknown | 0.25 mg/kg | Intravenous |
| Subject | HLX301 | Unknown | 1 mg/kg | Intravenous |
| Subject | HLX301 | Unknown | 2.5 mg/kg | Intravenous |
| Subject | HLX301 | Unknown | 5 mg/kg | Intravenous |
| Subject | HLX301 | Unknown | 10 mg/kg | Intravenous |
| Subject | HLX301 | Unknown | 15 mg/kg | Intravenous |