drugset / Trial / NCT03843918
A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer
NaSequentialOpen-labelTreatment
Summary
This study is a multicenter phase I/II study of the treatment of patients with metastatic prostate cancer. The objective of Phase I part is to study the safety and tolerability of LAE001 monotherapy in patients with metastatic castration-resistant prostate cancer, and determine the maximum tolerated dose (MTD) as well as the recommended phase II dose (RP2D) of the drug, the Phase II part is to assess the efficacy of LAE001 based on PSA in the treatment of patients with metastatic castration-resistant prostate cancer.
Timeline
- Start
- 2019-04-05
- Primary completion
- 2023-10-09
- Completion
- 2023-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CFG920 | Small molecule | 50 mg | Oral |
| Subject | CFG920 | Small molecule | 75 mg | Oral |
| Subject | CFG920 | Small molecule | 100 mg | Oral |
| Subject | CFG920 | Small molecule | 125 mg | Oral |