Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
Sponsor: Nurix Therapeutics, Inc.
ClinicalTrials ID:NCT07520006
This study assesses the safety and efficacy of bexobrutideg, a BTK degrader, with venetoclax and possibly an anti-CD20 antibody in CLL/SLL. Eligible participants must have ECOG 0-2, adequate organ function, and measurable disease. Interventions include oral NX-5948 and venetoclax, and IV rituximab or obinutuzumab. Prior BTKi treatment is required for R/R cases.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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).
Description
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
Eligibility Criteria
Inclusion Criteria
- 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
Key
Exclusion Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Cancer Centers | 80012 | Aurora | Colorado |
| University of Miami | 33146 | Coral Gables | Florida |
| Oncology Associates of Oregon | 97401 | Eugene | Oregon |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - Northeast | 75702 | Tyler | Texas |
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