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

Inclusion Criteria:

• 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

• Failed or are intolerant to ≥2 prior lines of systemic therapy

• ECOG Performance Status 0 to 2

• Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹/L, plateletcount ≥50 × 10⁹/L, hemoglobin ≥8 g/dL) not requiring transfusion support or growthfactors

• Adequate hepatic function

• Adequate renal function

• Ability to swallow tablets and comply with study requirements for the duration ofstudy participation

• Male and female patients of reproductive potential: Willing to observe conventionaland effective birth control methods

• Male patients: agree not to donate sperm during and for 6 months after the study

• Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) foran approved indication

Exclusion Criteria:

• Transformed disease (eg, Richter's transformation) prior to or during Screening

• Investigational agent or anticancer therapy within 5 half-lives before the plannedstart of docirbrutinib, except therapeutic monoclonal antibody treatment which mustbe discontinued at least 4 weeks before the start of docirbrutinib

• Current treatment with investigational therapy or planned investigational therapywhich 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 ofdocirbrutinib

• 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 thefirst dose of study treatment

• Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0Grade 2 at the time of starting study treatment except for alopecia

• History of allogeneic or autologous stem cell transplant or CAR-T therapy within thelast 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 concomitanttherapy escalated within the 4 weeks before study enrollment is required to maintainadequate blood counts

• Clinically significant, uncontrolled cardiac, cardiovascular disease or history ofmyocardial infarction within 6 months before planned start of docirbrutinib, orprolongation 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 beperformed at Screening

• Clinically significant active malabsorption syndrome or other condition likely toaffect 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 exceptpirtobrutinib (Jaypirca)

• Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalentBTKi