A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
AstraZeneca
Summary
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.
Description
This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of Surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
1. Key Inclusion Criteria: * Aged 18 years old and above * Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy * ECOG performance status 0 to 2 * Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy * FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension) * Adequate hematological function: ANC ≥ 1000/mm3, platelets *…
Interventions
- DrugSurovatamig
Investigational Product administered via intravenous infusion.
Locations (94)
- Research SitePhoenix, Arizona
- Research SiteDuarte, California
- Research SiteJacksonville, Florida
- Research SiteTampa, Florida
- Research SiteChicago, Illinois
- Research SiteIowa City, Iowa