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)

Launched by ADC THERAPEUTICS S.A. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial, called LOTIS-10, is studying a new treatment called loncastuximab tesirine for patients with certain types of lymphoma, specifically diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL), who have had their disease return or not respond to previous treatments. The focus is on understanding how the drug works in patients with moderate to severe liver problems, as well as determining the best dose for these individuals. The trial is currently recruiting participants aged 18 and older who meet specific health criteria.

To be eligible, participants must have a confirmed diagnosis of relapsed or refractory DLBCL or HGBCL and have received at least one prior treatment. They should also have measurable disease, meaning the cancer can be tracked, and their liver function will be assessed to categorize them into different groups based on the severity of liver impairment. Participants can expect to receive the study drug and undergo regular monitoring to assess its safety and effectiveness. It’s important to note that certain individuals, such as those with specific viral infections or significant prior treatments, may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female participants aged 18 years or older
• • Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen
• • Measurable disease as defined by the 2014 Lugano Classification
• * Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification:
• • Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN)
• • Arm B Moderate hepatic impairment: bilirubin \> 1.5 × to 3 × ULN (any AST)
• • Arm C Severe hepatic impairment: bilirubin \> 3 × ULN (any AST)
• • ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment
• • Adequate organ function
• • Women of childbearing potential (WOCBP)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug.
• Exclusion Criteria:
• • Previous therapy with loncastuximab tesirine
• • Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)
• • Human immunodeficiency virus (HIV) seropositive
• • Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
• • Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
• • History of Stevens-Johnson syndrome or toxic epidermal necrolysis
• • Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
• • Breastfeeding or pregnant
• • Significant medical comorbidities
• • Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor