Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NX-5948 + venetoclax | Experimental |
| |
| NX-5948 + venetoclax + rituximab | Experimental |
| |
| NX-5948 + venetoclax + obinutuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NX-5948 | Drug | Administered orally once daily as a capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Up to approximately 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to approximately 7 years |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Additional Site Contact Information | Contact | 415-417-3418 | clinicaltrials@nurixtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nurix Therapeutics, Inc. | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D000069283 | Rituximab |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| venetoclax | Drug | Administered orally once daily as a tablet per prescribing information |
|
| rituximab | Drug | Administered as an intravenous (IV) infusion per prescribing information |
|
| obinutuzumab | Drug | Administered as an IV infusion per prescribing information |
|
| 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 |
| 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 | 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. | 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 | Up to approximately 7 years |
| Overall survival | Time from the start date of study treatment to the date of death from any cause | Up to approximately 7 years |
| Pharmacokinetic profile of NX-5948 | NX-5948 concentrations in blood samples | Up to approximately 1 year |
| Pharmacokinetic profile of venetoclax | Venetoclax concentrations in blood samples | 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 | 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 | Baseline and up to approximately 27 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |