RecruitingPhase 1NCT05660395

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)

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)


Sponsor

ADC Therapeutics S.A.

Enrollment

56 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the body processes a cancer drug called loncastuximab tesirine in patients with a type of aggressive blood cancer (diffuse large B-cell lymphoma or high-grade B-cell lymphoma) who also have liver problems. Researchers want to understand if liver impairment changes how the drug works and whether dose adjustments are needed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or treatment-resistant diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma - You have had at least one prior treatment for your lymphoma - You have either normal liver function, moderate liver impairment, or severe liver impairment (the study has different arms for each) - You have measurable disease - You are in reasonably good health overall (ECOG 0–3 depending on liver status) **You may NOT be eligible if...** - You have not previously received any treatment for your lymphoma - Your disease does not meet the study's definition of relapsed or refractory - You are pregnant or breastfeeding, or unwilling to use contraception during and for months after the study - You have conditions that prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLoncastuximab 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

View Full Details on ClinicalTrials.gov

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NCT05660395