At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 128 enrolled
Drug / intervention
H3B-6527drug
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.
An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma
In Brief
A Phase 1 clinical trial evaluating H3B-6527 for Advanced Hepatocellular Carcinoma and 5 related conditions. Completed, enrolled 128 participants across 44 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms, Hepatic Cancer, Hepatic Carcinoma
CountriesBelgium, Canada, France, Italy, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsEisai Inc.
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartDec 2016
Primary CompletionFeb 2022
TodayJul 2026
First PostedJul 15, 2016
Enrollment StartDec 28, 2016
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.0 years ago
Interventions
H3B-6527drug
H3B-6527 by mouth once or twice daily at specified doses.