A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

A Phase 2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.

Inclusion Criteria

• Participants with histologically confirmed B-cell malignancy including:

  • Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen;
  • CLL/SLL treated with a prior BTK inhibitor containing regimen;
  • Other types of B-cell NHL

• All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required

• Eastern Cooperative Oncology Group 0-2

• Adequate hematologic status, coagulation, hepatic and renal function

Exclusion Criteria

• Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment
• Participants requiring therapeutic anticoagulation with warfarin
• Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded
• Significant cardiovascular disease
• Prolongation of the QT interval
• Test positive for human immunodeficiency virus (HIV)
• Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors
• Pregnancy or lactation
• Active second malignancy
• Prior treatment with LOXO-305
• Known hypersensitivity to any component or excipient of LOXO-305