Summary
This study has three parts, and will evaluate a new drug (called INCA033989) alone, or in combination with targeted therapy (called ruxolitinib). The study will recruit:
- People with myelofibrosis (MF).
- People with essential thrombocythemia (ET).
- People with myelofibrosis exhibiting suboptimal response (MF SubOptR).
In the Dose Escalation Part (Part 1a), people with MF and ET will receive INCA033989 as monotherapy, which will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]).
People with MF SubOptR will receive INCA033989, which will be administered at a protocol defined starting regimen in 28-day cycles and will allow for evaluation of INCA033989 in combination with targeted therapy (called ruxolitinib) to identify the MTD and/or RDE[s].
In the Dose Expansion Part (Part 1b), participants with MF and ET will receive INCA033989 as monotherapy at the RDE[s] identified during Part 1a.
Participants with MF-SubOpt R will receive INCA033989 as an add-on therapy in combination with ruxoclitinib at the RDE[s] identified during Part 1a.
In the Dose Expansion Part (Part 1c), INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with ruxolitinib. Participants with MF will enroll int his group. THe participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.