Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Surovatamig
  Investigational Product administered via intravenous infusion.

Первичные конечные точки

• Overall response rate (ORR) (central review) [Срок оценки: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.]

Вторичные конечные точки (12)

• Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI) [Срок оценки: From time of Informed Consent to 90-day safety follow-up visit]
• Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs) [Срок оценки: From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2]
• Duration of response (DoR) [Срок оценки: To be assessed up to approximately 5 years.]
• Complete response (CR) rate (central review) [Срок оценки: To be assessed up through study completion, up to approximately 5 years]
• Complete response (CR) rate (investigator assessment) [Срок оценки: To be assessed up through study completion, up to approximately 5 years]
• Overall response rate (ORR) (investigator assessment) [Срок оценки: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.]
• Duration of complete response (DoCR) [Срок оценки: To be assessed up to approximately 5 years.]
• Time to response (TTR) [Срок оценки: From the first dose until the first objective response, up to approximately 5 years.]
• Event-free survival (EFS) [Срок оценки: To be assessed up to approximately 5 years]
• Progression-free survival (PFS) [Срок оценки: To be assessed up to approximately 5 years.]
• Time to next anti-lymphoma (TTNT) [Срок оценки: To be assessed up to approximately 5 years.]
• Overall survival (OS) [Срок оценки: To be assessed up to approximately 5 years.]

Критерии участия

• 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

• 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
• 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:

• Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
• Active CNS involvement by B-NHL
• Leukemic presentation of B-NHL
• History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.
• Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
• Requires chronic immunosuppressive therapy
• Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
• History of major cardiac abnormalities.
• If female, participant must not be pregnant or breastfeeding.

The above is a summary, other exclusion criteria details may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 23 центра

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Япония · 8 центров

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Италия · 6 центров

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Германия · 5 центров

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Австралия · 4 центра

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Канада · 4 центра

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Франция · 4 центра

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Швеция · 2 центра

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Идентификаторы

NCT: NCT06526793 · D7404C00001 · 2023-505789-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗