Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Prior treatment

• Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor;
• Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product;
• Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product;

Other illness

• Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
• Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment;

Lab values

• Pregnant (positive serum pregnancy test) or lactating women;
• Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, one disease or state providing a reason to suspect that the subject is not suitable for HMPL-689 at the investigator's discretion, or one condition that will affect interpretation of the study results or bring the subject at high risk.

Other

• Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion;
• Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);
• Inadequate organ function of liver and kidney;

• Age ≥18 years;
• Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma
• Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;
• At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (the longest diameter of nodal lesion \> 1.5 cm or extranodal lesion \> 1 cm);
• Expected survival of more than 12 weeks;