A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
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
• 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, platelet count ≥50 × 10⁹/L, hemoglobin ≥8 g/dL) not requiring transfusion support or growth factors
• Adequate hepatic function
• Adequate renal function
• Ability to swallow tablets and comply with study requirements for the duration of study participation
• Male and female patients of reproductive potential: Willing to observe conventional and 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) for an approved indication