AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma

Exclusion Criteria24

• 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
• Current treatment with certain strong CYP3A4 inhibitors or inducers
• Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib
• Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors
• Refractory to transfusion support
• Major surgery within 4 weeks before planned start of docirbrutinib
• Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment
• Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia
• History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days
• Active second malignancy unless in remission with life expectancy \>2 years
• Known central nervous system (CNS) involvement by systemic lymphoma
• Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts
• Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) \>470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF \>470 msec on all 3 ECGs, during Screening
• Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
• Positive for HIV. For patients with unknown HIV status, HIV testing will be performed at Screening
• Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of docirbrutinib
• Pregnant or lactating.
• Known hypersensitivity to any component or excipient of docirbrutinib
• Prior treatment with docirbrutinib
• Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)
• Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi