drugset / Trial / NCT02966171
A Dose Escalation Study to Assess the Safety and Tolerability of HMPL-453 in Patients With Advanced Solid Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in patients with advanced or metastatic solid malignancies who have failed or are intolerable to standard therapies or for whom no standard therapies exist. There are preliminary two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). We will decide whether to conduct stage 2 or not one month after the last patient included in stage 1.
Timeline
- Start
- 2017-01
- Primary completion
- 2018-08-23
- Completion
- 2018-08-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HMPL-453 | Unknown | 25 mg | Oral |
| Subject | HMPL-453 | Unknown | 50 mg | Oral |
| Subject | HMPL-453 | Unknown | 100 mg | Oral |
| Subject | HMPL-453 | Unknown | 200 mg | Oral |
| Subject | HMPL-453 | Unknown | 300 mg | Oral |
| Subject | HMPL-453 | Unknown | 400 mg | Oral |
| Subject | HMPL-453 | Unknown | 500 mg | Oral |