CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
ginisortamab +2 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.

Search/NCT04393298
NCT04393298Phase 2Completed
CompareCT.gov

A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

UCB Biopharma SRL·interventional·Posted May 19, 2020·Updated May 29, 2025

In Brief

A Phase 2 clinical trial evaluating ginisortamab, trifluridine/tipiracil, and 1 other intervention for Advanced Solid Tumors. Completed, enrolled 93 participants across 9 sites in 2 countries.

Detailed Summary

The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114 administered as monotherapy or in combination with selected standard of care (SOC) regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 19, 2020
Enrollment StartJul 9, 2020
Primary CompletionApr 11, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.1 years ago

Interventions

ginisortamabdrug

Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.

trifluridine/tipiracildrug

Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.

mFOLFOX6drug

Study participants will receive predefined doses of oxaliplatin, Leucovorin and 5-fluorouracil as part of the mFOLFOX6 chemotherapy regimen administered as intravenous (iv) infusion at prespecified time points.