drugset / Trial / NCT05144061
A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors
NaSingle-groupOpen-labelTreatment
Summary
The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced malignant tumor ; Exploratory cohort is to explore the relationship between gene mutation and efficacy and resistance mechanisms.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2024-02-21
- Completion
- 2024-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HRS2398 | Unknown | 5 mg | Oral |
| Subject | HRS2398 | Unknown | 320 mg | Oral |