This is an open-label, multi-center Phase 1 study of LOXO-338 in patients with advanced hematologic malignancies who have received standard therapy. This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, Part 2 will evaluate the combination of LOXO-338 with LOXO-305.
Inclusion Criteria
- B-cell malignancy
- Prior therapy:
- CLL/SLL, MCL, or WM: received at least 2 prior lines of therapy
- Other NHL or MM: have failed standard therapy and, in the opinion of the investigator, have no options available known to provide benefit for the patient’s condition
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–2
Exclusion Criteria
- Known or suspected history of central nervous system (CNS) involvement
- History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within the past 60 days
- Known Human Immunodeficiency Virus (HIV) positive, regardless of CD4 count. Unknown or negative status eligible
Study Requirements
Part 1: LOXO-338 Monotherapy
There will be:
- Appropriate laboratories to monitor electrolytes including phosphate, calcium, uric acid, andcomplete blood count (CBC)
- Safety observations including physical examination, assessment of vital signs including bodyweight, ECOG PS, clinical AEs, laboratory variables (hematology, serum or plasma chemistries,and urinalysis), and electrocardiograms (ECGs)