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

Outcome

Outcome not reported

Stopped: “This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.”

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