A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.

Inclusion criteria

• Life expectancy ≥ 3 months
• Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
• Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
• Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
• Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Meet various hematological, liver function and renal function lab parameters

Exclusion criteria

• Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
• Current or history of central nervous system (CNS) lymphoma;
• Toxicity not yet recovered from previous anti-tumor therapies
• Uncontrolled systemic infections or infections requiring intravenous antibiotics
• Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
• Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
• Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
• Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
• Presence of active graft-versus-host disease
• Have undergone a major surgery within 28 days
• Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
• Have cardiac impairment as defined per protocol
• Have prior history of malignancies other than follicular lymphoma