Trials / Completed
CompletedNCT04060511
A Study of HS-10342 in Patients With Advanced Solid Tumor
A Phase 1, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10342 in Patients With Advanced Solid Tumor
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients. Preliminary efficacy will be also investigated in this study.
Detailed description
This is a phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10342 in patients with advanced solid tumor by using a "3+3" dose escalation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HS-10342 | HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID |
Timeline
- Start date
- 2019-06-19
- Primary completion
- 2020-12-04
- Completion
- 2021-09-15
- First posted
- 2019-08-19
- Last updated
- 2023-03-09
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04060511. Inclusion in this directory is not an endorsement.