A Study of GFH018 in Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05051241|
Recruitment Status : Not yet recruiting
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: GFH018||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||November 2022|
The duration of the first cycle is 31 days and the subsequent periods are 28 days.
Subjects will receive treatment with GFH018 until disease progression (clinically- or radiologically-confirmed), occurrence of intolerable toxicity, or subjects discontinue from the study treatment for other reasons.
Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen.
- Phase I：Incidence of dose-limiting toxicity (DLT) events [ Time Frame: 31 days after the first dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051241
|Contact: Jenny Liu||+86 21 6882 firstname.lastname@example.org|
|Shanghai East hospital|
|Contact: Jin Li, MD|
|Principal Investigator:||Jin Li, MD||Leading site|