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
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
The Oncology Institute of Hope & Innovation - Lynwood
COMPLETED
Lynwood
Other Locations
Brazil
Hospital Sírio-Libanês - Brasília
RECRUITING
Brasília
Hospital Mãe de Deus - Centro Integrado de Oncologia
RECRUITING
Porto Alegre
A Beneficência Portuguesa de São Paulo - Unidade Mirant
RECRUITING
São Paulo
Albert Einstein Israelite Hospital
RECRUITING
São Paulo
Hospital 9 de Julho
RECRUITING
São Paulo
Hospital Sírio-Libanês - São Paulo
RECRUITING
São Paulo
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Dong-A University Hospital
RECRUITING
Pusan
Korea University Anam Hospital
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
ADC Therapeutics
clinical.trials@adctherapeutics.com
954-903-7994
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2027-04-05
Participants
Target number of participants: 56
Treatments
Experimental: Arm A: Normal Hepatic Function
Participants will receive loncastuximab tesirine 0.15 mg/kg once every 3 weeks (Q3W) for two cycles, then 0.075 mg/kg Q3W for subsequent cycles (1 cycle = 21 days).~Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Experimental: Arm B: Moderate Hepatic Impairment
Participants will receive loncastuximab tesirine in a standard 3+3 dose-escalation design. Initial dose will be 0.09 mg/kg Q3W for two cycles, then 0.045 mg/kg Q3W for subsequent cycles (1 cycle = 21 days). The highest dose possibly administered will be 0.15 mg/kg Q3W.~Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Experimental: Arm C: Severe Hepatic Impairment
Participants will receive loncastuximab tesirine in a standard 3+3 dose-escalation design. Initial dose will be 0.09 mg/kg Q3W for two cycles, then 0.045 mg/kg Q3W for subsequent cycles (1 cycle = 21 days). The highest dose possibly administered will be 0.15 mg/kg Q3W.~Participants who have a toxicity meeting the criteria for dose reduction will have subsequent doses reduced by 50%. If the toxicity recurs, subsequent doses must be reduced by an additional 50%. A maximum of 2 dose reductions are allowed. Participants who have a toxicity meeting the criteria for dose reduction following Cycle 2 will receive the protocol-specified dose of 50% of initiate dose for Cycle 3, i.e., they will not have an additional dose reduction for Cycle 3.
Sponsors
Leads: ADC Therapeutics S.A.

This content was sourced from clinicaltrials.gov