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)

Last updated: June 20, 2024
Sponsor: ADC Therapeutics S.A.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Hematologic Cancer

Lymphoma

Treatment

Loncastuximab Tesirine

Clinical Study ID

NCT05660395
ADCT-402-107
2021-005209-29
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants aged 18 years or older

  • Pathologic diagnosis of relapsed (disease that has recurred following a response) orrefractory (disease that failed to respond to prior therapy) DLBCL not otherwisespecified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least onesystemic treatment regimen

  • Measurable disease as defined by the 2014 Lugano Classification

  • Normal hepatic function or hepatic impairment as defined by the National CancerInstitute Organ Dysfunction Working Group hepatic impairment classification:

  • Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤upper limit of normal (ULN)

  • Arm B Moderate hepatic impairment: bilirubin > 1.5 × to 3 × ULN (any AST)

  • Arm C Severe hepatic impairment: bilirubin > 3 × ULN (any AST)

  • ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0to 3 for participants with moderate or severe hepatic impairment

  • Adequate organ function

  • Women of childbearing potential (WOCBP)* must agree to use a highly effective methodof contraception from the time of giving informed consent until at least 10 monthsafter the last dose of study drug. Men with female partners who are of childbearingpotential must agree to use a condom when sexually active or practice totalabstinence from the time of the first dose until at least 7 months after the lastdose of study drug.

Exclusion

Exclusion Criteria:

  • Previous therapy with loncastuximab tesirine

  • Allogenic or autologous stem cell transplant within 60 days prior to start of studydrug (C1D1)

  • Human immunodeficiency virus (HIV) seropositive

  • Serologic evidence of chronic hepatitis B virus (HBV) infection and unable orunwilling to receive standard prophylactic antiviral therapy or with detectable HBVviral load

  • Serologic evidence of hepatitis C virus (HCV) infection without completion ofcurative treatment or with detectable HCV viral load

  • History of Stevens-Johnson syndrome or toxic epidermal necrolysis

  • Lymphoma with active central nervous system involvement at the time of screening,including leptomeningeal disease

  • Breastfeeding or pregnant

  • Significant medical comorbidities

  • Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by theSponsor

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: Loncastuximab Tesirine
Phase: 1
Study Start date:
August 28, 2023
Estimated Completion Date:
April 05, 2027

Connect with a study center

  • Hospital Sírio-Libanês - Brasília

    Brasília, 70200-730
    Brazil

    Active - Recruiting

  • Hospital Mãe de Deus - Centro Integrado de Oncologia

    Porto Alegre, 90110-270
    Brazil

    Active - Recruiting

  • A Beneficência Portuguesa de São Paulo - Unidade Mirant

    São Paulo, 01323-030
    Brazil

    Active - Recruiting

  • Albert Einstein Israelite Hospital

    São Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Hospital 9 de Julho

    São Paulo, 01409-002
    Brazil

    Active - Recruiting

  • Hospital Sírio-Libanês - São Paulo

    São Paulo, 01308-050
    Brazil

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Daegu Gwang'yeogsi 41944
    Korea, Republic of

    Active - Recruiting

  • Dong-A University Hospital

    Busan, Gyeongsangnam-do 602-812
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, Seongbuk District 02841
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi] 03080
    Korea, Republic of

    Active - Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, Taiwan 112
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • The Oncology Institute of Hope & Innovation - Lynwood

    Lynwood, California 90262
    United States

    Active - Recruiting

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