This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or
Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant
Myelofibrosis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04640532.
Cohorts 1 and 2 will undergo dose finding and dose expansion. Eligible patients will be
randomly assigned to an open cohort, either Cohort 1 or Cohort 2. Cohort 3 will be
conducted as a dose expansion, independent of Cohorts 1 and 2.
Cohort 1 will follow a 3+3 dose escalation design to determine the maximum tolerated dose
(MTD)/maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of TL-895
administered QD in combination with KRT-232. A Safety Review Committee (SRC) will review
the safety data during the dose escalation to decide on dose escalation and/or
exploration of intermediate doses.
Cohort 2 will follow a 3+3 dose escalation design to determine the MTD/MAD and
recommended RP2D of TL-895 administered BID in combination with KRT-232. An SRC will
review the safety data during the dose escalation to decide on dose escalation and/or
exploration of intermediate doses.
Cohort 3 will be conducted a 2-stage design. In stage 1, enrollment will continue until
15 evaluable patients have been enrolled. An SRC will review the data during the study
and if there are ≥4 responders based on the futility criteria and safety data from Stage
1, Cohort 3 expansion will commence. If there are ≤3 patients responding to therapy,
Cohort 3 will be terminated. Once expansion criteria have been met, Cohort 3 will be
expanded to a total of 46 evaluable patients for Stage 2 analyses.
Lead OrganizationKartos Therapeutics, Inc.
