drugset / Trial / NCT05171062
Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer
Phase 1
Withdrawn
The University of Texas Health Science Center at San Antonio
Faron Pharmaceuticals Ltd · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Treating with an antiCLEVER-1 antibody, such as bexmarilimab, could lead to immune system activation, which, in turn, may lead to cancer elimination.
Timeline
- Start
- 2023-06
- Primary completion
- 2025-12
- Completion
- 2026-12
Outcome
Outcome not reported
Stopped (Enrollment): “No participants were enrolled, the study was inactivated with the IRB on May 15, 2023. The sponsor notified the PI that a Phase II trial had been allowed to proceed by the FDA.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bexmarilimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | bexmarilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | bexmarilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | bexmarilimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |