drugset / Trial / NCT05015309
A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor
NaSequentialOpen-labelTreatment
Summary
The primary objective is to determine the safety and tolerability of SH3765 in subjects with advanced malignant tumor by determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The second objective is to evaluate the PK profile and preliminary efficacy of SH3765 in subjects with advanced malignant tumor.
Timeline
- Start
- 2021-09
- Primary completion
- 2023-03
- Completion
- 2024-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SH3765 | Unknown | 2.5 mg | Oral |
| Subject | SH3765 | Unknown | 5 mg | Oral |
| Subject | SH3765 | Unknown | 10 mg | Oral |
| Subject | SH3765 | Unknown | 15 mg | Oral |
| Subject | SH3765 | Unknown | 20 mg | Oral |
| Subject | SH3765 | Unknown | 25 mg | Oral |
| Subject | SH3765 | Unknown | 30 mg | Oral |