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)
← catalyst calendarSponsored by ADC Therapeutics S.A. (industry) · ADCT — their whole pipeline →.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
5actual
Sites
14
Countries
Brazil, South Korea, Taiwan +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
This decision to close the study was made following interactions with regulatory authorities and in consideration of the challenges associated with this patient population. No safety information contributed to this decision.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-28 | actual | When the study began enrolling |
| Primary completion | 2026-06-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-25 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diffuse Large B-Cell Lymphoma
- High-grade B-cell Lymphoma
Intervention
- Drug: Loncastuximab Tesirine — also filed as Zynlonta, ADCT-402
Primary outcome
what the primary-completion date above is the date OFNumber of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT)
measured Day 1 to Day 21 of Cycle 1, where a cycle is 21 days
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