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)
| NCT ID | NCT05660395 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ADC Therapeutics S.A. |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2023-08-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * Male or female participants aged 18 years or older * Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen * Measurable disease as defined by the 2014 Lugano Classification * Normal hepatic function or hepatic impairment as defined by the National Cancer Institute 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 0 to 3 for participants with moderate or severe hepatic impairment * Adequate organ function * Women of childbearing potential (WOCBP)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug. Exclusion Criteria: * Previous therapy with loncastuximab tesirine * Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1) * Human immunodeficiency virus (HIV) seropositive * Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load * Serologic evidence of hepatitis C virus (HCV) infection without completion of curative 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 the Sponsor
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05660395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05660395 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05660395 currently recruiting?
Yes, NCT05660395 is actively recruiting participants. Contact the research team at clinical.trials@adctherapeutics.com for enrollment information.
Where is the NCT05660395 trial being conducted?
This trial is being conducted at Lynwood, United States, Brasília, Brazil, Porto Alegre, Brazil, São Paulo, Brazil and 10 additional locations.
Who is sponsoring the NCT05660395 clinical trial?
NCT05660395 is sponsored by ADC Therapeutics S.A.. The trial plans to enroll 56 participants.