Trials / Completed
CompletedNCT05051241
A Study of GFH018 in Patients With Advanced Solid Tumors
A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GFH018 | Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen. Other dose regimens, eg 7d-on/7d-off will also be considered to be explored when the safety/tolerability is confirmed. |
Timeline
- Start date
- 2019-08-30
- Primary completion
- 2022-08-11
- Completion
- 2022-08-11
- First posted
- 2021-09-21
- Last updated
- 2024-03-01
- Results posted
- 2024-03-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05051241. Inclusion in this directory is not an endorsement.