NCT05280509 Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
| NCT ID | NCT05280509 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Telios Pharma, Inc. |
| Condition | Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-06-09 |
| Primary Completion | 2025-10 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 week