CC-95775-ST-001 is an open-label, Phase 1B, dose escalation and expansion study of CC-95775
in subjects with advanced or unresectable solid tumors, including laBCC, and relapsed/
refractory non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will
explore escalating oral doses of CC-95775 administered on a 4d on/24d off schedule to
estimate the MTD of CC-95775. A mTPI-2 will help guide CC-95775 dose escalation decisions
with the final decisions made by an SRC. Approximately 20 subjects will be enrolled.
The expansion cohort (Part B) will evaluate the safety, PK, PD safety and preliminary
activity of CC-95775 in advanced solid tumors, including laBCC. Approximately 20 subjects
will be enrolled.
Cedars Sinai, Los Angeles, California, United States
This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute
myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety,
pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more
intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has
been established for a treatment cohort, up to 20 additional patients may be enrolled in up
to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at
the recommended dose for future studies to confirm safety.