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

NCT05144061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Tumor

Interventions

DRUG

HRS2398 Tablets

Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle.

Sponsors & Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2024-02-21
Completion
2024-02-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144061 on ClinicalTrials.gov