A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients with Advanced Hematologic Malignancies

Protocol No
LOXO-BCL-20001
Principal Investigator
Guru Subramanian Guru Murthy
Phase
I
Summary
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 the highly selective, noncovalent Bruton’s tyrosine kinase (BTK) inhibitor, LOXO-305.
Description
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of oral LOXO-338 in patients with previously treated advanced hematologic malignancies.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL