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

• Status: Recruiting
• Trial end date: 2025-04-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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