Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

Inclusion Criteria

• Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme
• Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
• Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
• Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
• Age ≥ 18
• At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
• Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
• QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
• Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria

• Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
• Known lymphomatous involvement of the central nervous system
• Uncontrolled clinically significant illness
• Ongoing or history of drug-induced pneumonitis
• History of clinically significant cardiovascular abnormalities
• History of clinically significant GI conditions
• Known history of, or active HIV infection