Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: D'Angelo, Christopher
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04277637?term=NCT04277637&rank=1
Summary
Part 1: Sonrotoclax Monotherapy Dose Finding
Primary Objectives
Determine the safety and tolerability of sonrotoclax monotherapy and define the maximum tolerated dose (or maximum assessed dose; see Section 10.2.3) and the recommended Phase 2 dose of sonrotoclax monotherapy for the selected B-cell malignancy dose-finding cohorts
Evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types
Secondary Objective
Assess the pharmacokinetics of sonrotoclax
Exploratory Objective
Characterize the pharmacodynamics of sonrotoclax
Part 2: Sonrotoclax Monotherapy Expansion
Primary Objective
Evaluate the safety and tolerability of sonrotoclax monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Secondary Objectives
Evaluate the activity of sonrotoclax in the evaluated disease types as measured by overall response rate (and also by major response rate [MRR] for Waldenström macroglobulinemia [WM])
Evaluate food-effect on the pharmacokinetics of sonrotoclax
Further characterize the pharmacokinetics of sonrotoclax
Exploratory Objectives
Evaluate preliminary efficacy of sonrotoclax in the evaluated disease types as measured by time to response, duration of response, progression-free survival, and overall survival
Characterize the pharmacodynamics of sonrotoclax
Explore the correlation between biomarker characteristics and preliminary efficacy of sonrotoclax monotherapy in the evaluated disease types as measured by overall response rate, time to response, duration of response, progression-free survival, and overall survival
Explore resistance mechanisms to sonrotoclax
Assess relationships between sonrotoclax concentrations and changes in corrected QT interval, heart rate, and PR and QRS intervals
Assess depth of response by minimal residual disease assessment in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) cohorts
Explore the relative safety and tolerability of different ramp-up dosing schedules in the evaluated disease types
Exploratory Objectives
Evaluate preliminary efficacy of the combination of sonrotoclax and obinutuzumab with and without zanubrutinib in the evaluated disease types as measured by time to response, duration of response, progression-free survival, and overall survival
Evaluate the activity of the combination of sonrotoclax and obinutuzumab with and without zanubrutinib in patients with TN-CLL/SLL including MRD levels in blood and bone marrow
Explore the correlation between biomarker characteristics and preliminary efficacy of sonrotoclax when combined with obinutuzumab with and without zanubrutinib in patients with the evaluated disease types as measured by overall response rate, time to response, duration of response, progression-free survival, and overall survival
Explore resistance mechanisms
Further assess the pharmacokinetics of sonrotoclax when given in combination with obinutuzumab with and without zanubrutinib
Explore the relative safety and tolerability of different ramp-up dosing schedules in the evaluated disease types