Clinical Trial Details

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