Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Telios Pharma, Inc.
Study ID
NCT05280509
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis
  • Post-ET Myelofibrosis
  • Post-PV MF
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TL-895 — DRUG
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Ruxolitinib — DRUG
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.

Study Details

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.

Key Dates

Start date
Jun 9, 2022
Status verified
Feb 2023
Primary completion
Oct 31, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib [ Time Frame: 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Gabrail Cancer CenterCantonOhio44718-
University of Cincinnati (UC)CincinnatiOhio45267-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALGabrail Cancer Center· Canton, OHUniversity of Cincinnati (UC)· Cincinnati, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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