Trial Identifiers
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Scientific Title
A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis
Commercial Sponsor
Telios Pharma, Inc.
Summary
This is a randomised trial with multiple experimental arms. Experimental Arm 1a (relapsed/refractory Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2a (JAKi Intolerant Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2b (JAKi Intolerant Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3a (JAKi Ineligible Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3b (JAKi Ineligible Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 1 Expansion (Relapsed/Refractory Myelofibrosis) participants will receive TL-895 orally at RP2D and schedule. Experimental Arm 2 Expansion (JAKi Intolerant Myelofibrosis) will receive TL-895 orally at RP2D and schedule. Experimental Arm 3 Expansion (JAKi Ineligible Myelofibrosis) will receive TL-895 orally at RP2D and schedule.