drugset / Trial / NCT04999384
First in Human, Dose Escalation Study of AN4005
RandomizedSequentialQuadruple-blindTreatment
Summary
Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.
Timeline
- Start
- 2021-09-27
- Primary completion
- 2026-11
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AN4005 | Unknown | 50 mg | Oral |
| Comparator | AN4005 | Unknown | 100 mg | Oral |
| Comparator | AN4005 | Unknown | 200 mg | Oral |
| Comparator | AN4005 | Unknown | 400 mg | Oral |
| Comparator | AN4005 | Unknown | 600 mg | Oral |