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