Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers

Inclusion Criteria (Key factors listed):

Eastern Cooperative Oncology Group Performance Status of ≤2.
Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy
Presence of measurable disease through various assessments depending on specific cancer type.
Current medical need for therapy of the B-lymphoid malignancy.

Exclusion Criteria (Key factors listed):

Active central nervous system involvement.
History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers.
Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications.
Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy.
Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects.
Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit).