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

Purpose

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).

Conditions

  • B-cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NX-5948 + venetoclax
  • Drug: NX-5948
    Administered orally once daily as a capsule
    Other names:
    • bexobrutideg
  • Drug: venetoclax
    Administered orally once daily as a tablet per prescribing information
  • Drug: rituximab
    Administered as an intravenous (IV) infusion per prescribing information
  • Drug: obinutuzumab
    Administered as an IV infusion per prescribing information
Experimental
NX-5948 + venetoclax + rituximab
  • Drug: NX-5948
    Administered orally once daily as a capsule
    Other names:
    • bexobrutideg
  • Drug: venetoclax
    Administered orally once daily as a tablet per prescribing information
  • Drug: rituximab
    Administered as an intravenous (IV) infusion per prescribing information
Experimental
NX-5948 + venetoclax + obinutuzumab
  • Drug: NX-5948
    Administered orally once daily as a capsule
    Other names:
    • bexobrutideg
  • Drug: venetoclax
    Administered orally once daily as a tablet per prescribing information
  • Drug: obinutuzumab
    Administered as an IV infusion per prescribing information

Recruiting Locations

Rocky Mountain Cancer Centers
Aurora, Colorado 80012

Oncology Associates of Oregon
Eugene, Oregon 97401

SCRI Oncology Partners
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Nurix Therapeutics, Inc.

Study Contact

Additional Site Contact Information
415-417-3418
clinicaltrials@nurixtx.com

Detailed 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