for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion



Phase 1b (Dose Escalation) in primarily CLL/SLL patients will evaluate safety and pharmacology of self-administered twice a day oral doses beginning at 25 mg/dose for 4 weeks with succeeding cohorts at escalating doses until establishing dose limiting toxicity or, recommended Phase 2 dose. Patient data will be assessed before authorizing dose escalation cohorts. Phase 2 (Cohort Expansion) will follow in cohorts using the recommended dose to explore clinical activity, safety, pharmacology of SNS-062 (vecabrutinib) as monotherapy.

Official Title

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies


Phase 1b (Dose Escalation) This portion of the study will evaluate the safety and pharmacology of a range of SNS-062 (vecabrutinib) dose levels administered to subjects with previously treated B-lymphoid malignancies, including: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytoid lymphoma/Waldenström's macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma of the activated B-cell subtype (DLBCL-ABC), and follicular lymphoma (FL).

All subjects will self-administer SNS-062 orally BID. The dose-limiting toxicity (DLT) window will be 4 weeks (1 cycle in length). Assessments on study will be performed in 4-week cycles. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of SNS-062 using a standard 3+3 dose-escalation design.

Based on the pattern of dose-limiting toxicities (DLTs) observed in the first cycle (4 weeks), escalation will proceed to define a maximum tolerated dose (MTD) and/or a recommended dose (RD) that may be the MTD or a lower dose. An additional 6 subjects may be accrued at the MTD or the RD to confirm SNS-062 safety and pharmacology as a prelude to further clinical evaluation. Assessments regarding DLTs and dose escalation will be performed by a Safety Review Committee (SRC) comprising, but not limited to, the principal investigators, the medical monitor and the study sponsor drug safety representative.

Phase 2 (Cohort Expansion) This portion of the study provides cohort expansion to further explore the clinical activity, safety, and pharmacology of SNS-062 monotherapy. Accrual will occur independently for each of the 4 disease and mutation-specific cohorts. Subjects will self-administer SNS-062 orally at the RD of SNS-062 identified in the Phase 1b portion of the study. The SRC will meet regularly to assess the efficacy and safety for each cohort.


Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLymphoplasmacytoid LymphomaMantle-Cell LymphomaWaldenstrom MacroglobulinemiaDiffuse Large B Cell LymphomaFollicular LymphomaMarginal Zone LymphomaCLLhematological diseasesrelapsedcancermalignancySNS-062B-lymphoidWaldenström's macrogloulinemiamantle cell lymphomaSLLLPLWMMCLrefractoryDLBCL-ABCDLBCLdiffuse large B-cell lymphomaCLL/SLLMZLLymphomaLymphoma, FollicularLeukemia, LymphoidLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-CellLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Large B-Cell, Diffuse


You can join if…

Open to people ages 18 years and up

(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.
  • Presence of measurable disease through various assessments depending on specific cancer type.
  • Current medical need for therapy of the B-lymphoid malignancy due to disease-related symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or PD.

You CAN'T join if...

(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).


  • UC San Diego Moores Cancer Centeraccepting new patients
    San DiegoCalifornia92093United States
  • University of California Irvine Medical Centeraccepting new patients
    OrangeCalifornia92868-3201United States


accepting new patients
Start Date
Completion Date
Sunesis Pharmaceuticals
Phase 1/2
Study Type
Last Updated