A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies
The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.
• B-cell malignancy.
• Patients must have received prior therapy.
• Patients must have an objective indication for therapy.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
• Anticipated life expectancy of greater than or equal to (≥) 12 weeks.
• Adequate bone marrow function.
• Adequate hepatic function.
• Creatinine clearance of ≥ 60 milliliters (mL)/minute.
• Ability to swallow tablets.
• Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
• Prior treatment-related adverse events (AEs) must have recovered to grade less than or equal to (≤) 1 or pretreatment baseline, with the exception of alopecia.
• Men with partners of childbearing potential or women of childbearing potential (WOCBP) must agree to use highly effective birth control.
• WOCBP must not be pregnant.
• Additional Inclusion Criteria for Patients with AL Amyloidosis
‣ In Part 1 Dose Expansion, patients with AL amyloidosis are eligible based on prior detection of primary systemic light-chain amyloidosis.
⁃ Must have measurable disease of AL amyloidosis.
⁃ Prior local fluorescence in-situ hybridization (FISH) testing results for t(11;14) are required to be submitted prior to enrollment.