Trials / Completed
CompletedNCT05144061
A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of HRS2398 in Subjects With Advanced Malignant Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS2398 Tablets | Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle. |
Timeline
- Start date
- 2021-12-20
- Primary completion
- 2024-02-21
- Completion
- 2024-02-21
- First posted
- 2021-12-03
- Last updated
- 2024-12-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05144061. Inclusion in this directory is not an endorsement.