NCT04393298

A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ginisortamab	Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
DRUG	trifluridine/tipiracil	Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
DRUG	mFOLFOX6	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.

Timeline

• Start date: 2020-07-09
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2020-05-19
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study