A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
ADC Therapeutics S.A.
Summary
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
Description
This is a Phase 1b, multi-center, open-label, multi-arm study to evaluate the safety and anti-cancer activity of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab in participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL). The study will enroll approximately 200 participants. Loncastuximab tesirine (ADCT-402; Zynlonta) is an antibody drug conjugate (ADC), composed of a humanized monoclonal antibody directed against human cluster of differentiation 19 (CD19) conjugated through a cathepsin-cleavable linker to a pyrrolobenzodiaz…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participant 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) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2 * LBCL: Part 2 Arm E enrollment focused on LBCL only * DLBCL, not otherwise specified (NOS) * Germinal Center B-cell type * Activated B-c…
Interventions
- DrugLoncastuximab Tesirine
Intravenous (IV) infusion
- DrugPolatuzumab Vedotin
IV infusion
- DrugGlofitamab
IV infusion
- DrugMosunetuzumab
Subcutaneous (SC) injection
- DrugObinutuzumab
IV infusion
Locations (42)
- University of California San Francisco - Fresno Center for Medical Education and ResearchClovis, California
- Scripps Health - Prebys Cancer CenterSan Diego, California
- Sylvester Comprehensive Cancer CenterMiami, Florida
- Miami Cancer InstituteMiami, Florida
- Memorial Cancer Institute - Memorial Hospital WestPembroke Pines, Florida
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia