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)
Phase 1
56
about 3.6 years
18+
1 site in CA
Why this study is shown
What this study is about
This trial is testing a treatment called loncastuximab tesirine to see how it works and if it's safe for people with relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma who have liver problems. The goal is to find the best dose of this medication.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Loncastuximab Tesirine
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
loncastuximab tesirine
Primary: Number of Participants with Moderate or Severe Hepatic Impairment Who Experience a Dose-Limiting Toxicity (DLT)
Secondary: Apparent Clearance (CL) of Loncastuximab Tesirine and SG3199 in Serum, Apparent Terminal Elimination Half-life (Thalf) of Loncastuximab Tesirine and SG3199 in Serum, Complete Response (CR) Rate, Duration of Response (DOR), Maximum Concentration (Cmax) of Loncastuximab Tesirine and SG3199 in Serum, Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements, Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status, Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Values
Oncology