drugset / Trial / NCT07541534
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Timeline
- Start
- 2026-05-22
- Primary completion
- 2027-12-01
- Completion
- 2029-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HLX316 | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | HLX316 | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | HLX316 | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | HLX316 | Protein / enzyme biologic | 20 mg/kg | Intravenous |
| Subject | HLX316 | Protein / enzyme biologic | 30 mg/kg | Intravenous |
Indications
No indication recorded.