At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 172 enrolled
Drug / intervention
FGF401 +1 moredrug
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.
A Phase I/II, Multicenter, Open-label Study of Oral FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression
In Brief
A Phase 2 clinical trial evaluating FGF401 and PDR001 for Hepatocellular Carcinoma (HCC) and Solid Malignancies. Completed, enrolled 172 participants across 27 sites in 11 countries.
Detailed Summary
Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma (HCC), Solid Malignancies
CountriesChina, France, Germany, Hong Kong, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartDec 2014
Primary CompletionMay 2019
TodayJul 2026
First PostedDec 25, 2014
Enrollment StartDec 29, 2014
Primary CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.5 years ago
Interventions
FGF401drug
FGF401 is a FGFR4 inhibitor.
PDR001biological
PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2