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About
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.
Full 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 surovatamig (AZD0486) administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.
Enrollment
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Inclusion and exclusion criteria
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
Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN or < 5 × ULN in the presence of lymphoma involvement of the liver
Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA
The above is a summary, other inclusion criteria details may apply.
Key Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply.
Primary purpose
Allocation
Interventional model
Masking
270 participants in 2 patient groups
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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