This Phase II trial is evaluating how safe and effective a new drug (KER-050) is alone, and in combination with targeted therapy (ruxolitinib) in people with myelofibrosisA Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

Summary

This is a non-randomised, open-label trial with four experimental arms. In experimental arm 1a (dose escalation), participants will receive KER-050 monotherapy, administered via subcutaneous injection (SC) every 4 weeks, for up to 13 cycles. In experimental arm 1b (dose escalation), participants will receive KER-050, administered SC, every 4 weeks, for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily. In experimental arm 2a (dose expansion), participants will receive KER-050 monotherapy, administered SC, every 4 weeks, for up to 13 cycles. In experimental arm 2b, participants will receive KER-050, administered SC every 4 weeks for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily.