drugset
drugset / Trial / NCT05660395

A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)

NCT05660395 ↗

Phase 1 Terminated 5 enrolled ADC Therapeutics S.A.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.

Timeline

Start
2023-07-28
Primary completion
2026-06-25
Completion
2026-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Loncastuximab Tesirine Other / unclassified 0.045 mg/kg Intravenous
Subject Loncastuximab Tesirine Other / unclassified 0.075 mg/kg Intravenous
Subject Loncastuximab Tesirine Other / unclassified 0.15 mg/kg Intravenous

Indications

high grade B-cell lymphoma