drugset / Trial / NCT05144061

A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors

NCT05144061

Phase 1 Completed 28 enrolled Shanghai Hengrui Pharmaceutical Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject HRS2398 Unknown 5 mg Oral
Subject HRS2398 Unknown 320 mg Oral

Indications