NCT07508995

A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-arm, phase II study which will assess the safety and efficacy of BGB16673 in combination with sonrotoclax as a time-limited approach for participants with treatment-naive CLL/SLL.

Detailed description

Primary Objective: 1\. To evaluate the therapeutic activity (undetectable measurable residual disease \[U-MRD\] rate at 10-4 sensitivity) of the combination of the BTK degrader BGB-16673 and sonrotoclax in patients with previously untreated CLL/SLL Secondary Objectives: 1. To evaluate the therapeutic activity of the combination of BTK degrader BGB-16673 and sonrotoclax by determining the overall response rate (defined as complete remission/complete remission with incomplete count recovery/partial remission \[CR/CRi/PR\]) 2. To evaluate progression free survival (PFS) 3. To evaluate overall survival (OS) 4. To determine the safety and tolerability of the combination of BGB-16673 and sonrotoclax 5. To determine time to next treatment after discontinuation of BGB-16673 and sonrotoclax 6. To determine time to achievement of U-MRD with the combination of BGB-16673 and sonrotoclax Exploratory Objectives: 1. To study immunological and molecular changes in the peripheral blood and bone marrow in response to BGB-16673 and sonrotoclax 2. To evaluate the kinetics of MRD response over time

Conditions

• Chronic Lymphocytic Leukemia (CLL)

Interventions

Type	Name	Description
DRUG	BGB-16673	Given by mouth
DRUG	BGB-11417	Given by mouth

Timeline

• Start date: 2026-09-01
• Primary completion: 2031-07-01
• Completion: 2033-07-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study