CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
GFH018drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05051241
NCT05051241Phase 1Completed
CompareCT.gov

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

Zhejiang Genfleet Therapeutics Co., Ltd.·interventional·Posted Sep 21, 2021·Updated Mar 1, 2024

In Brief

A Phase 1 clinical trial evaluating GFH018 for Advanced Solid Tumor. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 21, 2021
Enrollment StartAug 30, 2019
Primary CompletionAug 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 4.8 years ago

Interventions

GFH018drug

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.