Actively Recruiting
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)
Led by ADC Therapeutics S.A. · Updated on 2025-07-16
56
Participants Needed
14
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the dosing and safety of loncastuximab tesirine in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) who also have moderate or severe liver problems. This phase 1b study aims to find the best dose for participants with different levels of liver impairment to help guide treatment decisions. The study includes participants with normal liver function as well as those with moderate or severe hepatic impairment. Participants receive loncastuximab tesirine through an intravenous infusion every three weeks. There are different dosing plans depending on liver function: one group gets 0.15 mg/kg for two cycles followed by 0.075 mg/kg thereafter, while others follow a dose-escalation design starting at 0.09 mg/kg then reducing to 0.045 mg/kg for later cycles. Dose reductions are allowed if participants experience certain toxicities, with a maximum of two dose reductions. Each cycle lasts 21 days. During the study, participants will be monitored for dose-limiting toxicities during the first cycle, and researchers will measure the drug's concentration and effects in the blood for up to one year. Safety assessments include tracking adverse events for up to three years. Other evaluations involve laboratory tests, vital signs, ECGs, and imaging to assess disease response and survival outcomes. The study may last several years, including long-term follow-up for safety and effectiveness.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma
- Received at least one systemic treatment regimen
- Measurable disease as defined by the 2014 Lugano Classification
- Normal hepatic function or moderate to severe hepatic impairment as defined by specific bilirubin and AST levels
- ECOG performance status 0 to 2 for normal hepatic function; 0 to 3 for moderate or severe hepatic impairment
- Adequate organ function
- Women of childbearing potential must agree to use effective contraception until 10 months after last dose
- Men with female partners of childbearing potential must use condoms or abstain until 7 months after last dose
You will not qualify if you...
- Previous therapy with loncastuximab tesirine
- Allogenic or autologous stem cell transplant within 60 days prior to study drug start
- HIV positive
- Chronic hepatitis B infection without or unwilling to take antiviral treatment or with detectable viral load
- Hepatitis C infection without completed curative treatment or with detectable viral load
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Active central nervous system lymphoma at screening
- Breastfeeding or pregnant
- Significant medical comorbidities
- Major surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 14 days before study drug start unless approved by Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive loncastuximab tesirine by intravenous infusion once every 3 weeks in cycles. Dose adjustments may occur based on toxicity. Treatment duration depends on individual response and tolerability.
1 visit every 3 weeks for infusion and assessments
Duration - Up to approximately 3 years
Participants are monitored for safety, adverse events, and long-term outcomes up to approximately 3 years after treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 14 locations
1
The Oncology Institute of Hope & Innovation - Lynwood
Lynwood, California, United States, 90262
Completed
2
Hospital Sírio-Libanês - Brasília
Brasília, Brazil, 70200-730
Actively Recruiting
3
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Brazil, 90110-270
Actively Recruiting
4
Hospital Sírio-Libanês - São Paulo
São Paulo, Brazil, 01308-050
Actively Recruiting
5
A Beneficência Portuguesa de São Paulo - Unidade Mirant
São Paulo, Brazil, 01323-030
Actively Recruiting
6
Hospital 9 de Julho
São Paulo, Brazil, 01409-002
Actively Recruiting
7
Albert Einstein Israelite Hospital
São Paulo, Brazil, 05652-900
Actively Recruiting
8
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi, South Korea, 41944
Actively Recruiting
9
Dong-A University Hospital
Pusan, Gyeongsangnam-do, South Korea, 602-812
Actively Recruiting
10
Korea University Anam Hospital
Seoul, Seongbuk District, South Korea, 02841
Active, Not Recruiting
11
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03080
Actively Recruiting
12
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
13
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
14
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, Taiwan 112
Actively Recruiting
Research Team
A
ADC Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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