Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

Key Inclusion Criteria:

- Diagnosis of follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic
lymphoma (SLL), chronic lymphocytic leukemia (CLL) (meeting International Workshop on
Chronic Lymphocytic Leukemia [IWCLL] Criteria 2008), mantle cell lymphoma (MCL),
Waldenstrom's macroglobulinemia (WM), or non-germinal center B-cell lymphoma (GCB)
diffuse large B-cell lymphoma (DLBCL) as documented by medical records on WHO criteria

- Prior treatment for FL, MZL, SLL, MCL, WM with ≥ 2 or for CLL or non-GCB DLBCL ≥ 1
chemotherapy-based or immunotherapy-based regimen, and not transplant eligible and
have had either progressive disease (PD) or no response to previous treatment

- For diseases other than Waldenstrom's macroglobulinemia (WM), presence of
radiographically measurable presence of ≥ 1 lesion that measures ≥ 2.0 cm in the
longest dimension (LD) and ≥ 1.0 cm in the longest perpendicular dimension (LPD)

- Eastern Cooperative Oncology Group (ECOG) ≤ 2

- Platelets ≥ 50 x 10^9/L; Hb ≥ 8.0 g/dL; absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L

- Without transfusion and growth factors within 7 days

- Aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2.5 x upper limit of normal
(ULN)

- Total bilirubin ≤ 1.5 x ULN

- Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min

- Not pregnant

- Willingness and ability to comply with protocol-specified Pneumocystis jirovecii
pneumonia (PJP) prophylaxis

Key Exclusion Criteria:

- Hepatitis B surface antigen (HBsAG) positive or hepatitis B core antibody positive

- Hepatitis C virus (HCV) antibody positive

- History of long QT syndrome or whose corrected QT(QTc) interval measured (Fridericia
method) at screening is prolonged (>450 ms)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.