An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Subjects with suboptimal response to ruxolitinib:
• Treatment with at a stable dose of ruxolitinib prior to study entry
• Subjects ≥ 18 years of age and able to provide informed consent.
• Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
• High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
• Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
RECRUITING
Halle
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
RECRUITING
Bologna
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
RECRUITING
Milan
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
RECRUITING
Perugia
Poland
Pratia Onkologia Katowice
RECRUITING
Katowice
Spain
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Quironsalud de Zaragoza
RECRUITING
Zaragoza
Contact Information
Primary
John Mei
jmei@teliospharma.com
650-542-0136
Backup
Nikki Stuart
nzona@teliospharma.com
Time Frame
Start Date:2022-06-09
Estimated Completion Date:2027-04
Participants
Target number of participants:70
Treatments
Experimental: Phase 1b - Dose Level 1
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
Experimental: Phase 1b - Dose Level 2
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
Experimental: Phase 1b - Dose Level 3
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
Experimental: Phase 2 - Cohort 1 JAKi treatment-naïve MF
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.~The dose of ruxolitinib will be based on the subject's baseline platelet count.
Experimental: Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.~The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.