Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

Официальное название

An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

Обзор

The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Подробное описание

Bexobrutideg is an investigational drug designed to target a protein called Bruton tyrosine kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. Bexobrutideg is a protein degrader, which means it finds and destroys the BTK in the cell. Venetoclax, rituximab, and obinutuzumab are approved medications that are used to treat CLL/SLL.

The study will look at:

* How safe bexobrutideg is for patients with CLL or SLL when taken with these other treatments * The effects of bexobrutideg in the body when taken with these other treatments * How well bexobrutideg treats CLL or SLL when taken with these other treatments

Вмешательства

• Препарат NX-5948
  Administered orally once daily as a capsule
• Препарат venetoclax
  Administered orally once daily as a tablet per prescribing information
• Препарат rituximab
  Administered as an intravenous (IV) infusion per prescribing information
• Препарат obinutuzumab
  Administered as an IV infusion per prescribing information

Первичные конечные точки

• Number of participants with treatment-emergent adverse events [Срок оценки: Up to approximately 7 years]

Вторичные конечные точки (10)

• Objective response rate as determined by investigator [Срок оценки: Up to approximately 7 years]
• Duration of response as determined by investigator [Срок оценки: Up to approximately 7 years]
• Progression-free survival as determined by investigator [Срок оценки: Up to approximately 7 years]
• Complete response rate as determined by investigator [Срок оценки: Up to approximately 7 years]
• Time to response as determined by investigator [Срок оценки: Up to approximately 7 years]
• Overall survival [Срок оценки: Up to approximately 7 years]
• Pharmacokinetic profile of NX-5948 [Срок оценки: Up to approximately 1 year]
• Pharmacokinetic profile of venetoclax [Срок оценки: Up to approximately 1 year]
• Change from baseline in Global Health Status/Quality of Life on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Baseline and up to approximately 27 months]
• Change from baseline in European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L) [Срок оценки: Baseline and up to approximately 27 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Adequate organ and bone marrow function
• Measurable disease by computed tomography (CT) per iwCLL
• For R/R CLL/SLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi)
• For 1L CLL/SLL, confirmed previously untreated CLL/SLL with a clinical indication for systemic treatment that meets iwCLL criteria
• Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate

Критерии исключения

• Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment
• Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment
• Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation
• Use of systemic corticosteroids (>20 mg/day prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast
• Previously treated with a BTK degrader
• Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment
• Known central nervous system (CNS) lymphoma or leukemia
• Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment
• Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment

Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07520006 · NX-5948-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗