drugset / Trial / NCT03256331
Evaluate the Safety of BEL-X-HG in Advanced Cancer Patients
Phase 1
Terminated
23 enrolled
Belx Bio-Pharmaceutical (Taiwan) Corporation
A2 Healthcare Taiwan Corporation · collab
SequentialOpen-labelTreatment
Summary
This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).
Timeline
- Start
- 2017-06-21
- Primary completion
- 2020-03-30
- Completion
- 2020-03-30
Outcome
Outcome not reported
Stopped (Enrollment): “In the light of the on-going COVID-19 pandemic and the resulted difficulty in patient recruitment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEL-X-HG | Unknown | 0.25 g | Oral |
| Subject | BEL-X-HG | Unknown | 0.5 g | Oral |
| Subject | BEL-X-HG | Unknown | 0.75 g | Oral |
| Subject | BEL-X-HG | Unknown | 1 g | Oral |
| Subject | BEL-X-HG | Unknown | 2 g | Oral |