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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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 - Adequate hematological, hepatic, & renal function.

Exclusion Criteria

Treatment-naive subjects: - Prior treatment with any JAKi Subjects with suboptimal response to ruxolitinib: - Documented disease progression while on ruxolitinib treatment All subjects: - Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment - Prior treatment with a BTK or BMX inhibitor

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 1b - Dose Escalation Design Phase 2 - Dose Expansion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug: Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
    Other names:
    • Jakafi
    • Jakavi
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.
  • Drug: TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug: Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
    Other names:
    • Jakafi
    • Jakavi
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.
  • Drug: TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug: Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
    Other names:
    • Jakafi
    • Jakavi
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.
  • Drug: TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug: Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
    Other names:
    • Jakafi
    • Jakavi
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.
  • Drug: TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug: Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
    Other names:
    • Jakafi
    • Jakavi

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Telios Pharma, Inc.

Study Contact

John Mei
650-542-0136
jmei@teliospharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.