This is a Phase 1 dose exploration study of LAM-002A administered by mouth in patients with
relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK) and
preliminary activity will be evaluated.
LAM-002A is supplied as 25 mg capsules and will be administered twice daily (BID) by mouth
with a cycle length of 28 days. Patients will be advised to take the doses at the same time
each day, approximately 12 hours apart on an empty stomach (no food within 2 hours prior to
dose, or within 2 hours after dose).
A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The MTD is defined
as the highest dose at which no more than 1 of 6 patients (i.e., < 33%) experiences a
dose-limiting toxicity (DLT) in the dose cohort.
Once the dose and schedule are established, additional patients will be treated to better
characterize the safety, tolerability, preliminary anti-tumor activity, PK and
pharmacodynamics of the study drug.