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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllTelios Pharma, Inc.
NCT05280509 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • TL-895
  • Ruxolitinib
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Where

19 sites
University of Alabama at Birmingham
Birmingham, United States
Gabrail Cancer Center
Canton, United States
University of Cincinnati (UC)
Cincinnati, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
CHU Angers
Angers, France
AP-HM - Hôpital de la Timone
Marseille, France
CHU de Nice - Hopital L'Archet II
Nice, France
Hôpital Saint Louis - AP-HP
Paris, France

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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