A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-Risk Primary or Secondary Myelofibrosis

Inclusion Criteria:

• Diagnosis of primary myelofibrosis (PMF) or secondary myelofibrosis (post-PV MF / post-ET MF)
• No longer respond to ruxolitinib or fedratinib or are ineligible to be treated with ruxolitinib or fedratinib
• Grade ≥ 2 bone marrow fibrosis as confirmed by bone marrow biopsy
• Enlarged Spleen
• Experience at least 2 symptoms (fatigue, night sweat, itching, abdominal discomfort, pain under left rib, bone pain, or fullness after beginning to eat)
• Platelet count ≥ 25K/uL
• Adequate kidney and liver function
• No spleen radiation within 6 months prior to screening
• No splenectomy
• No stem cell transplant at any time
• Not eligible for stem cell transplant within 3 months (unless not willing to undergo transplantation OR a suitable donor not available are considered as transplant ineligible)