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).
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered orally once daily as a capsule
Administered orally once daily as a tablet per prescribing information
Administered as an intravenous (IV) infusion per prescribing information
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGUniversity of Miami
Coral Gables, Florida, United States
NOT_YET_RECRUITINGOncology Associates of Oregon
Eugene, Oregon, United States
Number of participants with treatment-emergent adverse events
Time frame: Up to approximately 7 years
Objective response rate as determined by investigator
The percentage of participants with response as determined according to 2018 iwCLL guidelines; response includes complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), PR with lymphocytosis (PR-L), and nodular PR
Time frame: Up to approximately 7 years
Duration of response as determined by investigator
Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier
Time frame: Up to approximately 7 years
Progression-free survival as determined by investigator
Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier
Time frame: Up to approximately 7 years
Complete response rate as determined by investigator
The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines; includes CR + CRi for participants with CLL.
Time frame: Up to approximately 7 years
Time to response as determined by investigator
Time from the start date of study treatment to the date of the first assessment of a response
Time frame: Up to approximately 7 years
Overall survival
Time from the start date of study treatment to the date of death from any cause
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Administered as an IV infusion per prescribing information
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGTexas Oncology - Northeast
Tyler, Texas, United States
NOT_YET_RECRUITINGTime frame: Up to approximately 7 years
Pharmacokinetic profile of NX-5948
NX-5948 concentrations in blood samples
Time frame: Up to approximately 1 year
Pharmacokinetic profile of venetoclax
Venetoclax concentrations in blood samples
Time frame: 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)
Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30 questionnaire to assess the overall quality of life
Time frame: Baseline and up to approximately 27 months
Change from baseline in European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)
Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes
Time frame: Baseline and up to approximately 27 months