Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Loncastuximab Tesirine

Study Locations (14)

Other

  • Hospital Sírio-Libanês - Brasília — Brasília
  • Hospital Mãe de Deus - Centro Integrado de Oncologia — Porto Alegre
  • Hospital Sírio-Libanês - São Paulo — São Paulo
  • A Beneficência Portuguesa de São Paulo - Unidade Mirant — São Paulo
  • Hospital 9 de Julho — São Paulo
  • Albert Einstein Israelite Hospital — São Paulo
  • National Taiwan University Hospital — Taipei
  • Koo Foundation Sun Yat-Sen Cancer Center — Taipei

California

  • The Oncology Institute of Hope & Innovation - Lynwood — Lynwood

Daegu Gwang'yeogsi

  • Kyungpook National University Chilgok Hospital — Daegu

Gyeongsangnam-do

  • Dong-A University Hospital — Pusan

Seongbuk District

  • Korea University Anam Hospital — Seoul

Seoul Teugbyeolsi [Seoul-T'ukpyolshi]

  • Seoul National University Hospital — Seoul

Seoul Teugbyeolsi

  • Severance Hospital — Seoul

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2023-08-28
Est. Completion 2027-04-05
Phase Phase 1

Sponsor

ADC Therapeutics S.A.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05660395

The ClinicalTrials.gov registry entry for NCT05660395 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ADC Therapeutics S.A., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which Loncastuximab Tesirine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05660395 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Daegu Gwang'yeogsi. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05660395 about?

NCT05660395 is a clinical study titled "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)". 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.

What is the current status of trial NCT05660395?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2023-08-28. Estimated completion is 2027-04-05.

What conditions does trial NCT05660395 study?

This clinical trial studies the following conditions: Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05660395?

The interventions under investigation include: Loncastuximab Tesirine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05660395?

This trial is sponsored by ADC Therapeutics S.A., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05660395 being conducted?

This trial has 14 study locations across California, Daegu Gwang'yeogsi, Gyeongsangnam-do, Seongbuk District, Seoul Teugbyeolsi [Seoul-T'ukpyolshi]. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial