Trials / Recruiting
RecruitingNCT05660395
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- ADC Therapeutics S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Loncastuximab Tesirine | Intravenous (IV) Infusion |
Timeline
- Start date
- 2023-08-28
- Primary completion
- 2026-12-01
- Completion
- 2027-04-05
- First posted
- 2022-12-21
- Last updated
- 2025-07-16
Locations
14 sites across 4 countries: United States, Brazil, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05660395. Inclusion in this directory is not an endorsement.