drugset / Trial / NCT05934539
ALG.APV-527 First-in-human Study
NaSequentialOpen-labelTreatment
Summary
A first-in-human, multicenter, open-label, dose escalation and dose expansion phase 1 study in patients with advanced solid tumors to evaluate the safety of intravenously administered ALG.APV-527 (Short title: ALG.APV-527 first-in-human study). Adult patients with advanced/metastatic solid tumors likely to express 5T4 antigen who have failed standard of care regimens for their cancer, have become refractory to standard treatment, or for whom no effective therapy exists based on investigator judgment may be enrolled in this study. Part 1 (Dose Escalation): Approximately 36 evaluable patients planned to be enrolled. Part 2 (Dose Expansion): Approximately 20 evaluable patients planned to be enrolled.
Timeline
- Start
- 2022-12-23
- Primary completion
- 2024-01-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALG.APV-527 | Monoclonal antibody | 0.1 mg/kg | Intravenous |