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RECRUITING
NCT05660395
PHASE1

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)

Sponsor: ADC Therapeutics S.A.

View on ClinicalTrials.gov

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.

Official title: A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2023-08-28

Completion Date

2027-04-05

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

DRUG

Loncastuximab Tesirine

Intravenous (IV) Infusion

Locations (14)

The Oncology Institute of Hope & Innovation - Lynwood

Lynwood, California, United States

Hospital Sírio-Libanês - Brasília

Brasília, Brazil

Hospital Mãe de Deus - Centro Integrado de Oncologia

Porto Alegre, Brazil

Hospital Sírio-Libanês - São Paulo

São Paulo, Brazil

A Beneficência Portuguesa de São Paulo - Unidade Mirant

São Paulo, Brazil

Hospital 9 de Julho

São Paulo, Brazil

Albert Einstein Israelite Hospital

São Paulo, Brazil

Kyungpook National University Chilgok Hospital

Daegu, Daegu Gwang'yeogsi, South Korea

Dong-A University Hospital

Pusan, Gyeongsangnam-do, South Korea

Korea University Anam Hospital

Seoul, Seongbuk District, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Severance Hospital

Seoul, Seoul Teugbyeolsi, South Korea

National Taiwan University Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan