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).