This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.
Age ≥18 years
Provided written informed consent
Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL
Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion
Transformed disease (eg, Richter's transformation) prior to or during Screening
Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib
Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study
Requiring therapeutic anticoagulation with warfarin
Sequential
Docirbrutinib
Drugoral tablet, twice daily
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Dose escalation
Overall response rate (ORR) as assessed by investigator
Dose expansion
Number of patients with adverse events (AEs) and clinical laboratory abnormalities
Dose escalation, dose expansion
Area under the plasma concentration versus time curve (AUC) of docirbrutinib
Dose escalation, dose expansion
Peak Plasma Concentration (Cmax) of docirbrutinib
Dose escalation, dose expansion
Time to maximum plasma concentration (tmax) of docirbrutinib
Dose escalation, dose expansion
Proportion of patients with BTK and PLCG2 gene mutation before and after disease progression
Dose escalation, dose expansion
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