drugset / Trial / NCT07404332
5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I study to determine the optimal biological dose (OBD) of 5-Azacitidine in combination with PD-1/PD-L1 inhibitors in patients with tumors refractory to PD-1/PD-L1 inhibitors, for which such treatments have been approved.
Timeline
- Start
- 2026-02-11
- Primary completion
- 2028-02-28
- Completion
- 2031-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 5 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 10 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 15 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 25 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 50 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Cemiplimab | Monoclonal antibody | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |